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  • A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG). - NCT05099003

    Primary Objectives: 1. (Dose-finding phase) To define toxicities and estimate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of selinexor administered as an oral formulation in combination with standard of care radiation therapy (RT), to pediatric patients with newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG). 2. (Efficacy phase) To estimate the event-free survival (EFS) distribution for DMG/HGG patients and overall survival (OS) distribution for DIPG patients associated with selinexor plus RT, followed by selinexor in patients with newly diagnosed HGG (H3 K27M-mutant DMG or H3 K27-wild type HGG) or DIPG, and to compare those outcomes to historical controls.

    View All Details
    • Protocol Number:
      112203

    • Principal Investigator:
      Scott Moerdler M.D.

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Brain and Nervous System

    • Therapies Involved:
      Radiotherapy Chemotherapy single agent systemic

    • Drugs Involved:
      Selinexor (KPT-330)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Scott Moerdler M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • STEP 0: Patients must be >= 12 months and =< 21 years of age at the time of enrollment on Step 0.
    • Please note:
    • This age range includes pre-screening for all HGG patients. Individual treatment protocols may have different age criteria.
    • Non-DIPG patients with tumors that do not harbor an H3K27M-mutation and are >= 18 years of age will not be eligible to enroll on ACNS1821 (Step 1).
    • STEP 0: Patient is suspected of having localized, newly diagnosed HGG, excluding metastatic disease, OR patient has an institutional diagnosis of DIPG
    • STEP 0:
    • For patients with non-pontine tumors: Patient and/or their parents or legal guardians have signed informed consent for eligibility screening on APEC14B1 Part A.
    • For patients with DIPG: Patient and/or their parents or legal guardians have signed informed consent for ACNS1821.
    • STEP 0:
    • For patients with non-pontine tumors only, the specimens obtained at the time of diagnostic biopsy or surgery must be submitted through APEC14B1 ASAP, preferably within 5 calendar days of definitive surgery
    • STEP 1: Patients must be >= 12 months and =< 21 years of age at the time of enrollment
    • STEP 1: Patients must have newly-diagnosed DIPG or HGG (including DMG).
    • STEP 1: Stratum DIPG
    • Patients with newly-diagnosed typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of at least 2/3 of the pons on at least 1 axial T2 weighted image, are eligible. No histologic confirmation is required.
    • Patients with pontine tumors that do not meet radiographic criteria for typical DIPG (e.g., focal tumors or those involving less than 2/3 of the pontine cross-sectional area with or without extrapontine extension) are eligible if the tumors are biopsied and proven to be high-grade gliomas (such as anaplastic astrocytoma, glioblastoma, high-grade glioma not otherwise specified [NOS], and/or H3 K27M-mutant) by institutional diagnosis.
    • STEP 1: Stratum DMG (with H3 K27M mutation)
    • Patients must have newly-diagnosed non-pontine H3 K27M-mutant HGG without BRAF V600 or IDH1 mutations as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1
    • Note: Patients need not have either measurable or evaluable disease, i.e., DMG patients may have complete resection of their tumor prior to enrollment. Primary spinal tumors are eligible for enrollment. For rare H3 K27M-mutant HGG in non-midline structures (e.g., cerebral hemispheres), these patients will be considered part of Stratum DMG.
    • STEP 1: Stratum HGG (without H3 K27M mutation)
    • Patients must have newly-diagnosed non-pontine H3 K27M-wild type HGG without BRAF V600 or IDH1 mutations as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1
    • Please note:
    • Patients who fall in this category and who are >= 18 years of age are not eligible due to another standard-of-care regimen (radiation/temozolomide) that is available
    • Patients need not have either measurable or evaluable disease, i.e., HGG patients may have complete resection of their tumor prior to enrollment. Primary spinal tumors are eligible for enrollment
    • STEP 1: Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =<16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
    • STEP 1: Peripheral absolute neutrophil count (ANC) >= 1000/uL (within 7 days prior to step 1 enrollment)
    • STEP 1: Platelet count >= 100,000/uL (transfusion independent) (within 7 days prior to step 1 enrollment)
    • STEP 1: Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (within 7 days prior to step 1 enrollment)
    • STEP 1: Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 (within 7 days prior to step 1 enrollment) or A serum creatinine based on age/gender as follows (within 7 days prior to step 1 enrollment):
    • Age / Maximum Serum Creatinine (mg/dL)
    • 1 to < 2 years / male: 0.6; female: 0.6
    • 2 to < 6 years / male: 0.8; female: 0.8
    • 6 to < 10 years / male: 1; female: 1
    • 10 to < 13 years / male: 1.2; female: 1.2
    • 13 to < 16 years / male: 1.5; female: 1.4
    • >= 16 years / male: 1.7; female: 1.4
    • STEP 1: Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
    • STEP 1: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
    • STEP 1: Serum amylase =< 1.5 x ULN
    • STEP 1: Serum lipase =< 1.5 x ULN
    • STEP 1: No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination.
    • STEP 1: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.
    • STEP 1: Patients must be enrolled and protocol therapy must begin no later than 31 days after the date of radiographic diagnosis (in the case of non-biopsied DIPG patients only) or definitive surgery, whichever is the later date (Day 0). For patients who have a biopsy followed by resection, the date of resection will be considered the date of definitive diagnostic surgery. If a biopsy only was performed, the biopsy date will be considered the date of definitive diagnostic surgery.

    Exclusion Criteria:

    • STEP 1: Patients must not have received any prior therapy for their central nervous system (CNS) malignancy except for surgery and steroid medications.
    • STEP 1: Patients who are currently receiving another investigational drug are not eligible.
    • STEP 1: Patients who are currently receiving other anti-cancer agents are not eligible.
    • STEP 1: Patients >=18 years of age who have H3 K27M-wild type HGG.
    • STEP 1: Patients who have an uncontrolled infection.
    • STEP 1: Patients who have received a prior solid organ transplantation.
    • STEP 1: Patients with grade > 1 extrapyramidal movement disorder.
    • STEP 1: Patients with known macular degeneration, uncontrolled glaucoma, or cataracts.
    • STEP 1: Patients with metastatic disease are not eligible; MRI of spine with and without contrast must be performed if metastatic disease is suspected by the treating physician.
    • STEP 1: Patients with gliomatosis cerebri type 1 or 2 are not eligible, with the exception of H3 K27M-mutant bithalamic tumors.
    • STEP 1: Patients who are not able to receive protocol specified radiation therapy.
    • STEP 1:
    • Female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities.
    • Lactating females are not eligible unless they have agreed not to breastfeed their infants. It is not known whether selinexor is excreted in human milk.
    • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.
    • Sexually active patients of reproductive potential are not eligible unless they have agreed to use two effective methods of birth control (including a medically accepted barrier method of contraception, e.g., male or female condom) for the duration of their study participation and for 90 days after the last dose of selinexor. Abstinence is an acceptable method of birth control.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements. - NCT03093116

    Phase 1 Dose Escalation: (1)To determine the first cycle dose-limiting toxicities (DLTs) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. (2)To determine the maximum tolerated dose (MTD) of repotrectinib in adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. (3)To determine the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib for adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Phase 2 Study: (1)To determine the confirmed ORR as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Phase 1 Dose Escalation: (1)To evaluate the safety and tolerability of repotrectinib at various doses in subjects with advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. (2)To determine the effect of food on the pharmacokinetics (PK) of repotrectinib. (3)To determine the preliminary objective response rate by BICR (ORR) and clinical benefit rate (CBR) of repotrectinib, in subjects with advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. (4)To evaluate the potential of repotrectinib to induce cytochrome P450 3A (CYP3A) using midazolam as a probe substrate. Phase 2 Study: (1)To determine the DOR, time to response (TTR), and clinical benefit rate (CBR) of repotrectinib, as assessed by BICR, in each subject population expansion cohort of advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. (2)To estimate the progression-free survival (PFS) and overall survival (OS) of subjects treated with repotrectinib with advanced solid tumorsthat harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. (3)To evaluate the safety and tolerability of repotrectinib when administered at the RP2D in subjects with advanced solid tumors thatmharbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. (4)To determine the intracranial objective response rate (IC-ORR) of repotrectinib and Central Nervous System PFS (CNS-PFS) in subjects presenting with measurable brain metastases at baseline, using RANO- BM assessment (5)To assess the population PK of repotrectinib and to explore correlations between PK, response, and/or safety findings in subjects with advanced solid tumors with an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement (6)To assess treatment-related symptoms and general health status using validated instruments of subject-reported outcomes (EORTC-QLQ-C30 and LC-13 when applicable) in subjects treated with repotrectinib

    View All Details
    • Protocol Number:
      111906

    • Principal Investigator:
      Scott Moerdler M.D.

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Repotrectinib

      • Contacts:

      • Rutgers University Prinicipal Investigator: Scott Moerdler M.D.

    Read Inclusion & Exclusion Criteria

    PHASE 1

    Key Inclusion Criteria:

      1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) (Stage IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests. 2. ECOG PS 0-1. 3. Age ≥18 (or age ≥ 20 of age as required by local regulation). 4. Capability to swallow capsules intact (without chewing, crushing, or opening). 5. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed. 6. Prior cytotoxic chemotherapy is allowed. 7. Prior immunotherapy is allowed. 8. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1. 9. Patients with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria. 10. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance Within normal limits or > 40 mL/min; Total serum bilirubin < 1.5 × ULN; Liver transaminases (ASTs/ALTs) < 2.5 × ULN; < 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); < 2.5 × ULN; < 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation 11. Life expectancy ≥ 3 months.

      PHASE 2 Key Inclusion Criteria

        1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, or NTRK1-3 gene fusion. 2. Subject must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing using either: 1. a next-generation sequencing (NGS) or quantitative polymerase chain reaction (qPCR) test will be accepted to determine molecular eligibility. • Adequate tumor tissue needs to be sent to the Sponsor designated central diagnostic laboratory for retrospective confirmation by a central diagnostic laboratory test selected by the Sponsor. OR 2. a fluorescence in situ hybridization (FISH) test AND prospective confirmation of fusion status by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment will be accepted to determine molecular eligibility.
      • Adequate tumor tissue must be sent to the Sponsor designated central diagnostic laboratory for prospective confirmation by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 4. Age ≥12 (or age ≥ 20 as required by local regulation). 5. Willing and able to provide written institutional review board (IRB)/institutional ethics committee-approved Informed Consent or an Assent signed by a parent or legal guardian for subjects age 12 to 17. 6. At least 1 measurable target lesion according to RECIST (v1.1) prospectively confirmed by Blinded Independent Central Radiology Review (BICR), selected by Sponsor, PRIOR to enrollment. Subjects with CNS-only measurable disease ≥10 mm as defined by RECIST (v1.1) are eligible. 7. Subjects with advanced solid tumors harboring ROS1, NTRK1, NTRK2, or NTRK3 rearrangement will be assigned into 6 distinct expansion (EXP) cohorts provided all inclusion and exclusion criteria are met. i. EXP-1: ROS1 TKI-naïve ROS1+ NSCLC ii. EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC iii. EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) iv. EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) v. EXP-5: TRK TKI-naïve NTRK+ solid tumors vi. EXP-6: TRK TKI-pretreated NTRK+ solid tumors 8. Subjects with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria. 9. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance > 40 mL/min; Total serum bilirubin < 1.5 × ULN; Liver transaminases (ASTs/ALTs) < 2.5 × ULN; < 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); < 2.5 × ULN; < 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation 10. Life expectancy ≥ 3 months.

      Key Exclusion Criteria PHASE 1 and PHASE 2

        1. Concurrent participation in another therapeutic clinical trial. 2. Symptomatic brain metastases or leptomeningeal involvement. 3. History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected, requiring therapy within the previous 2 years. 4. Major surgery within 4 weeks of start of repotrectinib treatment. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation (≤10 fractions) must have been completed at least 48 hours prior to study entry 5. Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2 6. Any of the following cardiac criteria: Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTcF) > 470 msec obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval. 7. Known active infections (bacterial, fungal, viral including HIV positivity). 8. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption. 9. Peripheral neuropathy of CTCAE ≥grade 2. 10. History of extensive, disseminated, bilateral, or presence of CTCAE grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis. Subjects with history of prior radiation pneumonitis are not excluded.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients. - NCT02724579

    1. To estimate the progression-free survival (PFS) of children +/-3 years of age with WNT-driven average-risk medulloblastoma using reduced craniospinal radiotherapy (CSI) (18 Gy) with a limited target volume boost to the tumor bed of 36 Gy for a total of 54 Gy and reduced chemotherapy approach (no vincristine during radiotherapy and reduced-dose maintenance chemotherapy) and to monitor the PFS for early evidence that the outcome is unacceptable. 2. To prospectively test the hypothesis that DNA methylation profiling will accurately classify WNT-driven medulloblastoma. 3. To prospectively evaluate and longitudinally model the cognitive,social, emotional, behavioral and Quality of Life (QoL) functioning of children who are treated with reduced CSI (18 Gy) with a limited target volume boost to the tumor bed (to a total of 54 Gy) and reduced chemotherapy (reduced cisplatin, vincristine and CCNU) 4.To explore whether DNA methylation profiling of medulloblastoma samples will result in a predictive classification scheme for the Sonic Hedgehog (SHH) 5. To describe the audiologic and endocrinologic toxicities, as well as peripheral neuropathy in children treated with reduced CSI (18 Gy) with a limited target volume boost to the tumor bed (to a total of 54 Gy) and reduced cisplatin and vincristine chemotherapy.

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    • Protocol Number:
      111708

    • Principal Investigator:
      Richard Drachtman M.D.

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Brain and Nervous System

    • Therapies Involved:
      Radiotherapy Chemotherapy multiple agents systemic

    • Drugs Involved:
      LOMUSTINE MESNA CISPLATIN CYCLOPHOSPHAMIDE G-CSF VINCRISTINE

      • Contacts:

      • Rutgers University Prinicipal Investigator: Richard Drachtman M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients must be greater than or equal to 3 years and less than 22 years of age at the time of enrollment
    • Patients must be newly diagnosed and have:
    • Eligibility confirmed by rapid central pathology and molecular screening review on APEC14B1:
    • Classical histologic type (non LC/A) WNT medulloblastoma
    • Positive nuclear beta-catenin by immunohistochemistry (IHC)
    • Positive for CTNNB1 mutation by Sanger sequencing
    • Negative for MYC and MYCN by fluorescence in situ hybridization (FISH)
    • Patient must have negative lumbar cerebrospinal fluid (CSF) cytology
    • Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study; patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status; patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated; patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively
    • Patients must have eligibility confirmed by Rapid Central Imaging Review on APEC14B1; patients must have =< 1.5 cm^2 maximal cross-sectional area of residual tumor; whole brain magnetic resonance imaging (MRI) with and without gadolinium and spine MRI with gadolinium must be performed
    • Patients must be enrolled, and protocol therapy must be projected to begin, no later than 36 days after definitive diagnostic surgery (day 0)
    • Peripheral absolute neutrophil count (ANC) >= 1000/uL
    • Platelet count >= 100,000/uL (transfusion independent)
    • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
    • 3 to < 6 years of age: maximum (max) serum creatinine 0.8 mg/dL (males and females)
    • 6 to < 10 years of age: max serum creatinine 1 mg/dL (males and females)
    • 10 to < 13 years of age: max serum creatinine 1.2 mg/dL (males and females)
    • 13 to < 16 years of age: max serum creatinine 1.5 md/dL (males) and 1.4 md/dL (females)
    • >= 16 years of age: max serum creatinine 1.7 mg/dL (males) and 1.4 mg/dL (females)
    • The threshold creatinine values were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC)
    • Total or direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
    • Serum glutamate pyruvate (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (3x ULN); for the purpose of this study, the ULN for SGPT is 45 U/L
    • Central nervous system function defined as:
    • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
    • Patients must not be in status epilepticus, a coma or on assisted ventilation at the time of study enrollment
    • Patients must have receptive and expressive language skills in English, French, or Spanish to complete the QoL and neurocognitive assessments; if a patient meets these criteria but the parent/guardian speaks a language other than English, French, or Spanish, the patient may still be enrolled and tested, and the parent-report measures should be omitted
    • All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

    Exclusion Criteria:

    • Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible
    • Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids
    • Pregnancy and Breast Feeding
    • Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies
    • Lactating females are not eligible unless they have agreed not to breastfeed their infants
    • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
    • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
    • Patients with a history of moderate to profound intellectual disability (i.e., intelligence quotient [Q)]=< 55) are not eligible for enrollment; PLEASE NOTE: Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g., dyslexia) are eligible for this study. Children with posterior fossa syndrome (also known as cerebellar mutism) are eligible for this study

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Newark Beth Israel Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase 2 Study of Bevacizumab, Erlotinib and Atezolizumab in Subjects with Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) Associated or Sporadic Papillary Renal Cell Cancer. - NCT01130519

    Primary Objective: - To assess the complete response (CR) rate according to standard Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in patients with 1) advanced RCC associated with HLRCC and 2) advanced sporadic/non-HLRCC papillary renal cell cancer treated with a combination of bevacizumab, erlotinib, and atezolizumab. Secondary Objectives: - To determine the safety and tolerability of the combination of bevacizumab, erlotinib, and atezolizumab. - To determine the objective response rate (ORR) as complete response (CR) + partial response (PR). - To determine disease control rate (DCR) - confirmed response, or stable disease (SD) lasting for at least 6 months. - To assess progression-free survival time (PFS) according to RECIST 1.1. - To assess overall survival (OS). - To assess the duration of response. - To assess response to treatment using iRECIST.

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    • Protocol Number:
      082203

    • Principal Investigator:
      Ryan Stephenson

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Kidney

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      ERLOTINIB Atezolizumab (MPDL3280A) BEVACIZUMAB

      • Contacts:

      • Rutgers University Prinicipal Investigator: Ryan Stephenson

    Read Inclusion & Exclusion Criteria

    • INCLUSION CRITERIA: Patients must meet all the following criteria to be eligible for study enrolment:
    • Diagnosis of advanced renal cell cancer (RCC) associated with hereditary leiomyomatosis and renal cell cancer (HLRCC) (cohorts 1 & 3) or sporadicon-HLRCC papillary RCC (cohort 2 & 4)
    • Measurable disease outlined in Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    • No more than two prior regimens targeting the vascular endothelial growth factor (VEGF) pathway; no prior bevacizumab therapy
    • Age greater than or equal to 18 years.
    • Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
    • Patients must have normal organ and marrow function as defined below: white blood cell (WBC) count greater than or equal to 3,000/microL, absolute neutrophil count greater than or equal to 1,500/microL, platelet count greater than or equal to 100,000/microL, serum creatinine greater than or equal to 2 times the upper limit of reference range or creatinine clearance greater than or equal to 30 ml/min, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times the upper limit of reference range, total bilirubin less than 1.5 times the upper limit of reference range ( less than 3 x upper limit of reference range in patients with Gilbert's disease), alkaline phosphatase less than or equal to 2.5 times the upper limit of reference range (or less than or equal to 5 times the upper limit of reference range if considered to be related to liver or bone metastases by the principal investigator (PI)
    • Recovery from acute toxicity of prior treatment for RCC (to less than or equal to grade 1 the active version of Common Terminology Criteria for Adverse Events (CTCAE) or to a level permitted under other sections of Inclusion/ Exclusion criteria).
    • At least 4 weeks from completion of major surgery and a healed surgical incision
    • Negative pregnancy test (within 7 days of enrolment) in women of childbearing potential
    • No myocardial infarction, gastrointestinal (GI) perforation/fistula, intra-abdominal abscess, cerebrovascular accidents within six months prior to study entry
    • No coagulopathy or bleeding diathesis
    • Ability to understand and the willingness to sign a written informed consent document.
    • Archival tissue block or unstained tumor tissue available for correlative studies EXCLUSION CRITERIA:
    • Prior invasive malignancy of other histology, with the exception of adequately treated basal or squamous cell carcinoma of the skin, or any other malignancy for which the patient does not currently require treatment and/or has no evidence of disease for greater than or equal to 2 years.
    • Patients with known brain metastases unless treated with an appropriate modality with no evidence of progression/recurrence for greater than 3 months
    • Hypertension not controlled by medical therapy (resting systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg on at least two occasions over a 24 hour period despite optimal medical management).
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure (New York Heart Association grade III or greater), unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
    • Serious, non-healing wound or ulcer; bone fracture within 3 months prior to study entry
    • Patient known to be human immunodeficiency virus (HIV)-positive and requiring antiretroviral therapy (due to the risk of potential drug interactions)
    • Concomitant therapy with potent inhibitors of Cytochrome P450 3A4 (CYP450 3A4) (e.g., ketoconazole, verapamil etc.) or with potent CYP450 1A2 inhibitors (fluoroquinolone antibiotics including ciprofloxacin, levofloxacin, and norfloxacin; ticlodipine, cimetidine, amiodarone, etc. see Appendix C)
    • Pregnant women are excluded from this study because bevacizumab and erlotinib are anti-cancer agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated on this study
    • All men and women of childbearing potential must be willing to use effective contraception as determined by the principal investigator (including but not limited to abstinence, hormonal contraceptives (birth control pills, injections, or implants), intrauterine device (IUD), tubal ligation, vasectomy) from the time of enrolment to at least six months following the last dose of drug
    • Any known hypersensitivity to bevacizumab, erlotinib or other excipients of these drugs
    • Documented baseline proteinuria greater than 1000mg/day on 24-hour urine collection. Only patients with 1+ or greater proteinuria on urinalysis (UA) and a spot urine protein: creatinine ratio of greater than 0.5 will undergo a 24-hour urine collection for quantitation of proteinuria.
    • Left ventricular ejection fraction less than 40% as measured on transthoracic echocardiogram. INCLUSION OF WOMEN AND MINORITIES: Both men and women and members of all races and ethnic groups are eligible for this trial.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2 Study of Blinatumomab in Combination with Nivolumab, a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged < 1 to < 31 Years Old with First Relapse. - NCT04546399

    - To compare rate of minimal residual disease (MRD) negative second remission after up to two cycles of Reinduction with blinatumomab vs. blinatumomab/nivolumab in Group 1 patients aged; 1 to < 31 years old with first relapse of CD19+ B-ALL. - To compare EFSPI (EFS post-Induction) between Consolidation with blinatumomab vs. blinatumomab/nivolumab in Group 3 patients aged; 1 to <31 years old with first relapse of CD19+ B-ALL. - To evaluate the safety and tolerability of blinatumomab/nivolumab in patients aged 1 to < 31 years old with first relapse of CD19+ B ALL. - To compare EFSPI between blinatumomab vs. blinatumomab/nivolumab in Group 2 patients aged; 1 to < 31 years old with first relapse of CD19+ B-ALL. In Group 1 patients, compare EFS between blinatumomab monotherapy and blinatumomab/nivolumab arms as compared to similar patients treated on the predecessor trial AALL1331. In Group 1 patients: compare toxicity as defined by Grade 3 or greater adverse events during the first cycle of blinatumomab or blinatumomab/nivolumab to similar patients treated with Block 1 of cytotoxic chemotherapy on the predecessor trial AALL1331. In Group 2 patients with MRD; 0.1% after VXLD, compare MRD negative second remission (Rem-2) rate after the first cycle of immunotherapy between blinatumomab monotherapy and blinatumomab/nivolumab arms. In patients with Down syndrome (DS) with first relapse of B-ALL, describe the safety, tolerability and efficacy (as defined by MRD negative second remission, Rem-2) after up to two cycles of blinatumomab/nivolumab.

    View All Details
    • Protocol Number:
      112011

    • Principal Investigator:
      Richard Drachtman M.D.

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Blinatumomab (AMG103) Opdivo (Nivolumab)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Richard Drachtman M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients must be >= 1 and < 31 years at time of enrollment
    • Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:
    • Isolated bone marrow relapse
    • Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse
    • Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes
    • Patients with Down syndrome (DS) are eligible in the following categories:
    • Isolated bone marrow relapse
    • Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse
    • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
    • Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay
    • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
    • Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression
    • Radiation therapy (RT): >= 3 months must have elapsed if prior RT. This includes any patient requiring urgent radiation to any sites of extramedullary disease prior to enrollment (e.g. retinal/optic nerve involvement)
    • Hematopoietic stem cell transplant (HSCT): Patients must not have had a prior hematopoietic stem cell transplant
    • A single intrathecal chemotherapy at the time of relapse will be allowed. If < 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted
    • In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroid and/or hydroxyurea only) is permissible
    • Group 1 and Down syndrome patients who received pre-enrollment therapy and have a white blood count (WBC) >= 30,000/ul at the time of enrollment must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no "washout" is required
    • Group 1 and Down syndrome patients who received pre-enrollment therapy and have a WBC < 30,000/ul at the time of enrollment must be given a 24 hour "washout" before starting immunotherapy
    • Note: There is no waiting period or "washout" for patients who relapse while receiving upfront therapy
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows (within 7 calendar days prior to enrollment):
    • Age: Maximum serum creatinine (mg/dL)
    • 1 to < 2 years: 0.6 (male), 0.6 (female)
    • 2 to < 6 years: 0.8 (male), 0.8 (female)
    • 6 to < 10 years: 1 (male), 1 (female)
    • 10 to < 13 years: 1.2 (male), 1.2 (female)
    • 13 to < 16 years: 1.5 (male), 1.4 (female)
    • >= 16 years: 1.7 (male), 1.4 (female)
    • Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram
    • No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination
    • All patients and/or their parents or legal guardians must sign a written informed consent
    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

    Exclusion Criteria:

    • Patients with B-lymphoblastic lymphoma (B-LLy)
    • Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
    • Patients with Philadelphia chromosome positive (Ph+) B-ALL
    • Patients with mixed phenotype acute leukemia (MPAL)
    • Patients with known Charcot-Marie-Tooth disease
    • Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype
    • Patients with active, uncontrolled infection defined as:
    • Positive bacterial blood culture within 48 hours of study enrollment
    • Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline.
    • Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for > 48 hours
    • A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection
    • Active viral or protozoal infection requiring IV treatment
    • Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible
    • Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement
    • Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved
    • Patients with an active known/suspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
    • Group 1 and DS patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are not eligible
    • Note: Group 2 and 3 patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease
    • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. Patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab. Men receiving nivolumab and who are sexually active with WOCBP must continue contraception for 7 months after the last dose of nivolumab
    • Lactating females are not eligible unless they agree not to breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Newark Beth Israel Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase 2 Study of Dabrafenib with Trametinib after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG). - NCT03919071

    Primary: 1. To estimate the event-free survival (EFS) distribution for newly-diagnosed patients with BRAFV600-mutant high-grade glioma (HGG) without H3 K27M mutations excluding anaplastic pleomorphic xanthoastrocytoma (aPXA) and anaplastic ganglioglioma (aGG) treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib and to compare this EFS to contemporary historical controls. Secondary: 1. To describe the overall survival (OS) distribution for newly-diagnosed patients with BRAFV600-mutant HGG without H3 K27M mutations excluding aPXA and aGG treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib 2. To describe the EFS and overall survival (OS) distribution for newly-diagnosed patients with BRAFV600E-mutant aPXA and aGG without H3 K27M mutations treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib. 3. To describe the EFS and overall survival (OS) distribution for newly-diagnosed patients with BRAFV600E-mutant HGG including aPXA and aGG with H3 K27M mutations treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib 4. To define and evaluate the toxicities of combination therapy with dabrafenib and trametinib after radiation therapy in newly-diagnosed patients with HGG. Exploratory: 1. To bank tumor specimens and body fluids (blood, urine and cerebrospinal fluid) for future studies.

    View All Details
    • Protocol Number:
      112302

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Brain and Nervous System

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Trametinib DABRAFENIB

      • Contacts:

      • RWJBarnabas Health - Newark Beth Israel Medical Center Prinicipal Investigator: Teena Bhatla

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • PRE-ENROLLMENT ELIGIBILITY SCREENING: Patients must be =< 25 years of age at the time of enrollment on APEC14B1 Part A CNS/HGG pre-enrollment eligibility screening.
    • Note: This required age range applies to the pre-enrollment eligibility screening for all HGG patients. Individual treatment protocols may have different age criteria.
    • PRE-ENROLLMENT ELIGIBILITY SCREENING: Patient is suspected of having localized newly-diagnosed HGG, excluding metastatic disease.
    • PRE-ENROLLMENT ELIGIBILITY SCREENING: Patient and/or their parents or legal guardians have signed informed consent for eligibility screening on APEC14B1 Part A.
    • PRE-ENROLLMENT ELIGIBILITY SCREENING: The specimens obtained at the time of diagnostic biopsy or surgery must be submitted through APEC14B1 as soon as possible (ASAP), preferably within 5 calendar days of the procedure.
    • Please note: See the APEC14B1 Manual of Procedures for a full list of detailed instructions for submitting required materials and for shipping details.
    • Patients must be >= 3 years and =< 25 years of age at the time of enrollment.
    • Patients must have eligibility confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1
    • Newly diagnosed high-grade glioma with BRAF^V600-mutation
    • Results for H3 K27M by immunohistochemistry (IHC) or sequencing
    • Histologically confirmed high-grade glioma (World Health Organization [WHO] grade III or IV) including but not limited to: anaplastic astrocytoma (AA), anaplastic pleomorphic xanthoastrocytoma (aPXA), anaplastic gangliogliomas (aGG), glioblastoma (GB), and high-grade astrocytoma, not otherwise specified (NOS).
    • Patients must have had histologic verification of a high-grade glioma diagnosis. CSF cytology by lumbar puncture must be done if clinically indicated and determined to be safe prior to study enrollment. If cytology proves positive, the patient would be considered to have metastatic disease and would, therefore, be ineligible.
    • A pre- and post-operative brain MRI with and without contrast and a baseline spine MRI with contrast must be obtained prior to enrollment. The requirement for a post-operative MRI is waived for patients who undergo biopsy only. If the spine MRI is positive, the patient would be considered to have metastatic disease and would be ineligible.
    • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age.
    • Peripheral absolute neutrophil count (ANC) >= 1000/uL (within 7 days prior to enrollment).
    • Platelet count >= 100,000/uL (transfusion independent) (within 7 days prior to enrollment).
    • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (within 7 days prior to enrollment).
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 (within 7 days prior to enrollment) or
    • A serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
    • Age 3 to < 6 years (Male 0.8 mg/dL, Female 0.8 mg/dL)
    • Age 6 to < 10 years (Male 1 mg/dL, Female 1 mg/dL)
    • Age 10 to < 13 years (Male 1.2 mg/dL, Female 1.2 mg/dL)
    • Age 13 to < 16 years (Male 1.5 mg/dL, Female 1.4 mg/dL)
    • Age >= 16 years (Male 1.7 mg/dL, Female 1.4 mg/dL)
    • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and
    • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L.
    • Patients with a seizure disorder may be enrolled if their seizures are well controlled while on non-enzyme inducing anticonvulsants permitted on this study.
    • All patients and/or their parents or legal guardians must sign a written informed consent
    • Patients must be enrolled and protocol therapy must be projected to begin no later than 31 days after definitive surgery (day 0). If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery.

    Exclusion Criteria:

    • Patients with intrinsic brainstem or primary spinal cord tumors will be excluded.
    • Patients with metastatic disease (defined as neuraxis dissemination either by imaging or by cytology) will be excluded.
    • Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant for the treatment of HGG other than surgical intervention and/or corticosteroids.
    • Previous treatment with dabrafenib or another RAF inhibitor, trametinib or another MEK inhibitor, or an ERK inhibitor.
    • Patients with a history of a malignancy with confirmed activating RAS mutation.
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib, trametinib, and their excipients.
    • Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease, or uncontrolled infection), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
    • Presence of active gastrointestinal (GI) disease or other condition (e.g., small bowel or large bowel resection) that will interfere significantly with the absorption of drugs.
    • History of hepatitis B virus, or hepatitis C virus infection (patients with laboratory evidence of cleared hepatitis B virus and/or hepatitis C virus may be enrolled).
    • History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following:
    • Recent myocardial infarction (within the last 6 months);
    • Uncontrolled congestive heart failure;
    • Unstable angina (within last 6 months);
    • Clinically significant (symptomatic) or known, uncontrolled cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular [AV] block without a pacemaker) except sinus arrhythmia within the past 24 weeks prior to the first dose of study treatment;
    • Coronary angioplasty or stenting (within last 6 months);
    • Intra-cardiac defibrillators;
    • Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram.
    • Patients with a history or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR), or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension).
    • Patients with presence of interstitial lung disease or pneumonitis.
    • Female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities.
    • Lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of the study and for 4 months following discontinuation of study therapy.
    • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.
    • Sexually active patients of reproductive potential (male or female) are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 4 months following discontinuation of study therapy. Male patients (including those who have had a vasectomy) taking dabrafenib and trametinib combination therapy must use a condom during intercourse while on study and for 16 weeks after stopping treatment, and should not father a child during these periods. Women of childbearing potential should use effective non-hormonal contraception during therapy and for 4 weeks following discontinuation of dabrafenib and at least 4 months following the last dose of trametinib in patients taking combination therapy. Women should be advised that dabrafenib may decrease the efficacy of hormonal contraceptives and an alternate method of contraception, such as barrier methods, should be used.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor. - NCT04684368

    Primary Aims: 1. To monitor outcome to ensure that children and young adults with localized central nervous system (CNS) non-germinomatous germ cell tumors (NGGCT) treated with Induction chemotherapy followed by response evaluation and whole ventricular + spinal canal irradiation (WVSCI) will maintain the excellent 2-year progression free survival (PFS) rate as compared to ACNS0122. 2. To improve disease control by decreasing the number of spinal relapses for patients who achieve a complete response (CR) or partial response (PR) and receive WVSCI as compared to whole ventricular radiation on ACNS1123. 3. To estimate the response rates to Induction chemotherapy and WVSCI for localized NGGCT patients who achieve a CR/PR. 4. To estimate the PFS and OS for localized NGGCT patients who achieve a CR/PR and receive WVSCI. 5. To estimate the PFS and OS for patients with less than a CR/PR following Induction who subsequently receive HDCSCR. 6. To estimate the response rate for patients with less than a CR/PR following Induction who subsequently receive HDCSCR.

    View All Details
    • Protocol Number:
      112104

    • Principal Investigator:
      Scott Moerdler M.D.

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Brain and Nervous System

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      IFOSFAMIDE Thiotepa CARBOPLATIN MESNA ETOPOSIDE FILGRASTIM

      • Contacts:

      • Rutgers University Prinicipal Investigator: Scott Moerdler M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients must be >= 3 years and < 30 years at the time of study enrollment
    • Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or > 10 ng/mL or human chorionic gonadotropin (hCG) beta > 100 mIU/mL as confirmed by Rapid Central Marker Screening Review on APEC14B1-CNS. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 31 days prior to enrollment and start of protocol therapy [repeat if necessary]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy [repeat if necessary]). Basal ganglia or other primary sites are excluded
    • Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present. Patients with only mature teratoma are excluded. Patients with pure germinoma admixed with mature teratoma are excluded (would be eligible for pure germinoma protocols)
    • Patients must have a cranial MRI with and without gadolinium at diagnosis/prior to enrollment. If surgical resection is performed, patients must have pre-operative and post operative brain MRI with and without gadolinium. The post operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required (within 31 days prior to study enrollment and start of protocol therapy )
    • Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment. Spine MRI with and without gadolinium is recommended (within 31 days prior to study enrollment and start of protocol therapy)
    • Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery
    • Patients must have RAPID CENTRAL TUMOR MARKER REVIEW CSF tumor markers obtained prior to enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first
    • Peripheral absolute neutrophil count (ANC) >= 1000/uL (within 7 days prior to enrollment)
    • Platelet count >= 100,000/uL (transfusion independent) (within 7 days prior to enrollment)
    • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (within 7 days prior to enrollment)
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
    • Age: Maximum serum creatinine (mg/dL)
    • 3 to < 6 years: 0.8 (male), 0.8 (female)
    • 6 to < 10 years: 1 (male), 1 (female)
    • 10 to < 13 years: 1.2 (male), 1.2 (female)
    • 13 to < 16 years: 1.5 (male), 1.4 (female)
    • >= 16 years: male (1.7), 1.4 (female)
    • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
    • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment)
    • Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
    • Central nervous system function defined as:
    • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
    • Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment
    • Protocol therapy must begin within 31 calendar days of definitive surgery or clinical diagnosis, whichever is later. If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery.
    • All patients and/or their parents or legal guardians must sign a written informed consent
    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
    • NEUROCOGNITIVE FUNCTION AND QUALITY OF LIFE ASSESSMENT:
    • English-, Spanish-, or French- speaking
    • Note: Patients who speak a language other than English, Spanish, or French will be allowed to participate in ACNS2021 but will not complete the neurocognitive and quality of life assessments
    • No known history of neurodevelopmental disorder prior to diagnosis of NGGCT (e.g., Down syndrome, fragile X, William syndrome, intellectual disability). Patients with NF1 will be allowed to participate
    • Additional eligibility criteria for the COG Standardized Neuropsychological Battery only: must be at a site that has a psychologist to administer the battery
    • Note: If not eligible for the COG Standardized Battery, patients should still complete the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), Pediatric Quality of Life Inventory (PedsQL), Adaptive Behavior Assessment System Third Edition (ABAS-3), and Behavior Assessment System for Children, Third Edition (BASC-3) questionnaires

    Exclusion Criteria:

    • Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus)
    • Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis
    • Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids
    • Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination)
    • Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs
    • Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards
    • Lactating females who plan to breastfeed their infants
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma. - NCT05235165

    Primary Objective: To determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma. Secondary Objectives: - To determine if open surgical resection is superior to thoracoscopy for event free survival (EFS) in patients with resectable oligometastatic pulmonary osteosarcoma. - To determine if open surgical resection is superior to thoracoscopy for overall survival (OS) in patients with resectable oligometastatic pulmonary osteosarcoma. - To determine if thoracoscopy is superior to open surgical resection for post-operative pain interference in patients with resectable oligometastatic pulmonary osteosarcoma.

    View All Details
    • Protocol Number:
      112201

    • Principal Investigator:
      Scott Moerdler M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Bones and Joints,Lung

    • Therapies Involved:
      Surgery

      • Contacts:

      • Rutgers University Prinicipal Investigator: Scott Moerdler M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients must be < 50 years at the time of enrollment.
    • Patients must have =< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being >= 3 mm and all of which must be =< 3 cm size.
    • Note: Patient must have eligibility confirmed by rapid central imaging review.
    • Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
    • Patients must have a histological diagnosis of osteosarcoma.
    • Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
    • Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.
    • Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
    • Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.

    Exclusion Criteria:

    • Patients with unresectable primary tumor.
    • Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).
    • Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
    • Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.
    • Patients with evidence of extrapulmonary metastatic disease.
    • Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
    • All patients and/or their parents or legal guardians must sign a written informed consent.
    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Randomized Study of Selumetinib versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma. - NCT03871257

    1: To determine whether the efficacy of treatment with selumetinib as measured by event-free survival (EFS) is non-inferior to treatment with carboplatin/vincristine (CV) in previously untreated Neurofibromatosis type 1 (NF1)-associated low- grade glioma (LGG). 2: To determine whether visual acuity (VA) using Teller Acuity Cards (TAC), in patients with NF1-associated LGG within the optic pathway, is better in those treated with selumetinib. 3: To estimate tumor response rates and overall survival (OS) in each treatment regimen in previously untreated NF1-associated LGG. 4: To evaluate VA outcomes utilizing HOTV letter acuity testing in previously untreated NF1-associated LGG within the optic pathway in patients who are old enough to perform visual acuity testing utilizing HOTV (a recognition acuity measure). 5: To describe the improvement in motor function as measured by the Vineland scale in patients with previously untreated NF1-associated LGG that have documented motor deficits at enrollment. 6: To prospectively evaluate and compare the quality of life among patients treated with selumetinib or CV. 7: To prospectively evaluate and compare the cognitive, social, emotional, and behavioral functioning of patients with NF1-associated LGG treated with either selumetinib or CV. 8: To evaluate optical coherence tomography (OCT) measures of retinal axon and ganglion cell thickness as a marker of treatment response in previously untreated NF1-associated LGG within the optic pathway. 9: To compare novel, semi-automated volumetric MRI measures to traditional measurements of treatment response (bi-dimensional MRI measurements) in NF1- associated optic pathway tumors. 10: To obtain paired blood and tumor tissue to be banked for future NF1-LGG biology studies involving comprehensive molecular analysis, including but not limited to whole exome and RNA sequencing.

    View All Details
    • Protocol Number:
      111914

    • Principal Investigator:
      Scott Moerdler M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Brain and Nervous System

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic

    • Drugs Involved:
      VINCRISTINE Selumetinib CARBOPLATIN

      • Contacts:

      • Rutgers University Prinicipal Investigator: Scott Moerdler M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients must be >= 2 years and =< 21 years at the time of enrollment
    • Patients must have a body surface area (BSA) of >= 0.5 m^2 at enrollment
    • Patients must have neurofibromatosis type 1 (NF1) based on clinical criteria and/or germline genetic testing
    • Patients must be newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
    • For patients with optic pathway gliomas (OPGs):
    • Newly-diagnosed patients with OPG are eligible if there are neurologic symptoms (including visual dysfunction, as defined below) or other exam findings associated with the tumor
    • Previously-diagnosed patients with OPG are eligible if they have new or worsening neurologic symptoms (including visual dysfunction, as defined below) or have tumor growth
    • For both newly-diagnosed and previously-diagnosed OPG, the patient may be eligible, irrespective of whether there has been tumor growth or other neurological symptoms or worsening, if they meet at least one of the following visual criteria:
    • Visual worsening, defined as worsening of visual acuity (VA) or visual fields (VF) documented within the past year (by examination or history); OR
    • Significant visual dysfunction (defined as VA worse than normal for age by 0.6 logMAR [20/80, 6/24, or 2.5/10] or more in one or both eyes)
    • For patients with LGG in other locations (i.e., not OPGs):
    • Newly-diagnosed patients with LGG are eligible if there are neurologic symptoms or other exam findings associated with the tumor
    • NOTE: Newly-diagnosed patients with LGG without associated neurologic symptoms or exam findings are not eligible
    • Previously-diagnosed patients with LGG are eligible if they have new or worsening neurologic symptoms or have tumor growth
    • Although not required, if a biopsy/tumor resection is performed, eligible histologies will include all tumors considered LGG or low-grade astrocytoma (World Health Organization [WHO] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma
    • Patients must have two-dimensional measurable tumor >= 1 cm^2
    • Patients with metastatic disease or multiple independent primary LGGs are allowed on study
    • Creatinine clearance or radioisotope glomerular filtration Rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender (within 7 days prior to enrollment) as follows:
    • Age; maximum serum creatinine (mg/dL)
    • 2 to < 6 years; 0.8 (male) and 0.8 (female)
    • 6 to < 10 years; 1 (male) and 1 (female)
    • 10 to < 13 years; 1.2 (male) and 1.2 (female)
    • 13 to < 16 years; 1.5 (male) and 1.4 (female)
    • >= 16 years; 1.7 (male) and 1.4 (female)
    • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect [unconjugated] bilirubin levels as long as their direct [conjugated] bilirubin is < 3.1 mg/dL)
    • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limit of normal (ULN) = 135 U/L (within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L
    • Albumin >= 2 g/dL (within 7 days prior to enrollment)
    • Left ventricular ejection fraction (LVEF) >= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (within 4 weeks prior to enrollment)
    • Corrected QT (QTc) interval =< 450 msec by electrocardiography (EKG) (within 4 weeks prior to enrollment)
    • Absolute neutrophil count >= 1,000/uL (unsupported) (within 7 days prior to enrollment)
    • Platelets >= 100,000/uL (unsupported) (within 7 days prior to enrollment)
    • Hemoglobin >= 8 g/dL (may be supported) (within 7 days prior to enrollment)
    • Patients with a known seizure disorder should be stable and should have not experienced a significant increase in seizure frequency within 2 weeks prior to enrollment
    • Patients 2-17 years of age must have a blood pressure that is =< 95th percentile for age, height, and gender at the time of enrollment. Patients >= 18 years of age must have a blood pressure =< 130/80 mmHg at the time of enrollment (with or without the use of antihypertensive medications).
    • Note: Adequate blood pressure can be achieved using medication for the treatment of hypertension
    • All patients must have ophthalmology toxicity assessments performed within 4 weeks prior to enrollment
    • For all patients, an MRI of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site(s) of primary disease) with and without contrast must be performed within 4 weeks prior to enrollment
    • For patients who undergo a surgery on the target tumor (not required), a pre- and post-operative* MRI of the brain (with orbital cuts for optic pathway tumors) or spine (depending on the site(s) of primary disease) with and without contrast must also be performed within 4 weeks prior to enrollment
    • The post-operative MRIs should be performed ideally within 48 hours after surgery if possible
    • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
    • Patients must have the ability to swallow whole capsules
    • Patients must have receptive and expressive language skills in English or Spanish to complete the quality of life (QOL) and neurocognitive assessments
    • All patients and/or their parents or legal guardians must sign a written informed consent.
    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

    Exclusion Criteria:

    • Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted
    • Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible
    • Patients may not be receiving any other investigational agents
    • Patients with any serious medical or psychiatric illness/ condition, including substance use disorders likely in the judgement of the investigator to interfere or limit compliance with study requirements/treatment are not eligible
    • Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible
    • Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
    • Lactating females who plan to breastfeed their infants are not eligible
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 12 weeks after stopping study therapy are not eligible
    • Note: Women of child-bearing potential and males with sexual partners who are pregnant or who could become pregnant (i.e., women of child-bearing potential) should use effective methods of contraception for the duration of the study and for 12 weeks after stopping study therapy to avoid pregnancy and/or potential adverse effects on the developing embryo
    • Cardiac conditions:
    • Known genetic disorder that increases risk for coronary artery disease. Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented
    • Symptomatic heart failure
    • New York Heart Association (NYHA) class II-IV prior or current cardiomyopathy
    • Severe valvular heart disease
    • History of atrial fibrillation
    • Ophthalmologic conditions:
    • Current or past history of central serous retinopathy
    • Current or past history of retinal vein occlusion or retinal detachment
    • Patients with uncontrolled glaucoma
    • If checking pressure is clinically indicated, patients with intraocular pressure (IOP) > 22 mmHg or ULN adjusted by age are not eligible
    • Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor, or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN), such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study
    • Treatments and/or medications patient is receiving that would make her/him ineligible, such as:
    • Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E
    • Surgery within 2 weeks prior to enrollment, with the exception of surgical placement for vascular access or cerebrospinal fluid (CSF) diverting procedures such as endoscopic third ventriculostomy (ETV) and ventriculo-peritoneal (VP) shunt.
    • Note: Patients must have healed from any prior surgery prior to enrollment
    • Patients who have an uncontrolled infection are not eligible

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations. - NCT04293562

    1. To compare event-free survival (EFS) in children with de novo AML without FLT3 mutations who are randomly assigned to standard induction therapy on Arm A (DA-GO) with daunorubicin, cytarabine (DA) and gemtuzumab ozogamicin (GO) versus Arm B with CPX-351 and GO. 2. To compare overall survival (OS) and rates of end of Induction 1 (EOI1) minimal residual disease (MRD) in children with de novo AML without FLT3 mutations who are randomly assigned to standard induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B). 3. To estimate the EFS and rate of EOI1 MRD in FLT3 internal tandem duplication mutation positive patients (FLT3/ITD+; as defined by allelic ratio > 0.1) without favorable cytomolecular characteristics (NPM1 and/or CEBPA) receiving gilteritinib in combination with DA GO (Arm AC). 4. To estimate the EFS and rate of EOI1 MRD in patients with non-ITD FLT3 activating mutations who receive backbone therapy (DA-GO or CPX-351 and GO) with gilteritinib (Arms AD and BD). 5. To determine the feasibility of combining gilteritinib and DA-GO or CPX-351 and GO in patients with FLT3/ITD mutations (Arm AC/Arm BC/Arm AD/Arm BD). 6. To compare EOI1 MRD and EFS in patients with FLT3/ITD AML+ (AR > 0.1) without favorable cytogenetic/molecular characteristics treated with DA-GO-gilteritinib vs CPX-GO-gilteritinib (Arm AC vs Arm BC). 7. To compare the incidence of significant left ventricular systolic dysfunction (LVSD) in children with de novo AML without FLT3 mutations who are randomly assigned to standard induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B). 8. To compare the changes in echocardiography-derived measures of cardiac function, including left ventricular ejection fraction (EF) and global longitudinal strain (GLS), throughout AML therapy in patients with low and high risk AML without FLT3 mutations receiving Arm A vs Arm B. 9. Determine if early changes in sensitive echocardiographic measures of cardiac function (i.e., post-Induction 1 decline in GLS) and elevations in circulating cardiac biomarkers (i.e., cardiac troponin T and N-terminal pro b-type natriuretic peptide) are associated with subsequent declines in left ventricular ejection fraction in patients with non-FLT3 mutant AML receiving therapy on Arms A or B. 10. To compare longitudinal acute changes in neuropsychological functioning and neurocognitive late effects between those with CNS disease and those without CNS disease and between those treated with HSCT and those treated with chemotherapy only for patients on Arms A and B. 11. To compare cardiotoxicity measures (EF, GLS, and cardiac biomarkers) in patients receiving standard induction with dexrazoxane vs. CPX-351 in the context of gilteritinib therapy and explore whether the differential cardiotoxicity across arms varies from that observed in non-FLT3 mutant AML without gilteritinib exposure. 12. To estimate the EFS and rate of EOI1 MRD in patients with high allelic ratio (HAR) FLT3/ITD+ patients, as historically defined by an AR > 0.4, receiving gilteritinib in combination with DA-GO (Arm AC with AR > 0.4). 13. To estimate the EFS and rate of EOI1 MRD in FLT3/ITD+ patients (as defined by allelic ratio > 0.1) with NPM1 and/or bZIP CEBPA mutations receiving gilteritinib in combination with DA-GO (Arm AC). 14. Compare the changes in high sensitivity troponin and natriuretic peptide elevations throughout AML therapy, as measured at the end of each chemotherapy course, in patients with low and high risk AML without FLT3 mutations receiving Arm A vs Arm B

    View All Details
    • Protocol Number:
      112008

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, not otherwise specified

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      CPX-351 Gilteritinib

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Marissa Botwinick MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures
    • Patients must be less than 22 years of age at the time of study enrollment
    • Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease
    • Patient must have 1 of the following:
    • >= 20% bone marrow blasts (obtained within 14 days prior to enrollment)
    • In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy
    • < 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)
    • A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment)
    • ARM C: Patient must be >= 2 years of age at the time of Late Callback
    • ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology
    • ARM C: Patient does not have any congenital long QT syndrome or congenital heart block
    • ARM C: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib
    • ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib
    • ARM C: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib
    • ARM D: Patient must be >= 2 years of age at the time of Late Callback
    • ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating mutations as reported by Foundation Medicine
    • ARM D: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib
    • ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib
    • ARM D: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib
    • NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who transfer to Arm C or Arm D are not eligible
    • NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment
    • NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking
    • NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental retardation)
    • NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli
    • All patients and/or their parents or legal guardians must sign a written informed consent
    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

    Exclusion Criteria:

    • Fanconi anemia
    • Shwachman Diamond syndrome
    • Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21
    • Telomere disorders
    • Germline predispositions known, or suspected by the treating physician to increase risk of toxicity with AML therapy
    • Any concurrent malignancy
    • Juvenile myelomonocytic leukemia (JMML)
    • Philadelphia chromosome positive AML
    • Mixed phenotype acute leukemia
    • Acute promyelocytic leukemia
    • Acute myeloid leukemia arising from myelodysplasia
    • Therapy-related myeloid neoplasms
    • Patients with persistent cardiac dysfunction prior to enrollment, defined as ejection fraction (EF) < 50% (preferred method Biplane Simpson's EF) or if EF unavailable, shortening fraction (SF) < 24%. *Note: if clinically safe and feasible, repeat echocardiogram is strongly advised in order to confirm cardiac dysfunction following clinical stabilization, particularly if occurring in the setting of sepsis or other transient physiologic stressor. If the repeat echocardiogram demonstrates an EF >= 50%, the patient is eligible to enroll and may receive an anthracycline-containing Induction regimen
    • Administration of prior anti-cancer therapy except as outlined below:
    • Hydroxyurea
    • All-trans retinoic acid (ATRA)
    • Corticosteroids (any route)
    • Intrathecal therapy given at diagnosis
    • In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be avoided from the time of enrollment until it is determined whether the patient will receive gilteritinib. Patients receiving gilteritinib will be required to avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the study treatment
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
    • Lactating females who plan to breastfeed their infants
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
    • ARM D: Patient does not have any congenital long QT syndrome or congenital heart block

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Newark Beth Israel Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Randomized Trial of Inotuzumab Ozogamicin for Newly Diagnosed High-Risk B-ALL, Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy. - NCT03959085

    Primary Objective: 1. Improvement in 5-year disease-free survival (DFS) after adding 2 blocks of inotuzumab ozogamicin (InO) to Berlin-Frankfurt-Munster (mBFM) chemotherapy in children and young adults with High-Risk (HR) B-ALL. Secondary: 1. To describe the 5-year DFS for a favorable risk subset of NCI HR B-ALL (HR-Fav) when treated with mBFM chemotherapy with a single high-dose methotrexate (HD-MTX) Interim Maintenance (IM) phase and treatment duration of 2 years from the start of IM regardless of sex. 2. To determine the toxicity and tolerability of inotuzumab ozogamicin integrated into the mBFM chemotherapy backbone in HR B-ALL. 3. To describe the 5-year event-free survival (EFS) for patients with Mixed Phenotype Acute Leukemia (MPAL) receiving mBFM HR B-ALL therapy that includes a second IM phase with Capizzi escalating intravenous (IV) methotrexate (MTX) without leucovorin rescue plus pegaspargase (C-MTX). 4. To describe the 5-year EFS for patients with disseminated (Murphy stage III-IV) B-cell lymphoblastic lymphoma (B-LLy) receiving mBFM HR B-ALL therapy that includes a second IM phase with C-MTX.

    View All Details
    • Protocol Number:
      111911

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      CYTARABINE CYCLOPHOSPHAMIDE VINCRISTINE Pegaspargase (Oncaspar) LEUCOVORIN DAUNORUBICIN MERCAPTOPURINE THIOGUANINE METHOTREXATE

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Marissa Botwinick MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.
    • APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.
    • Patients must be > 365 days and < 25 years of age
    • White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):
    • Age 1-9.99 years: WBC >= 50,000/uL
    • Age 10-24.99 years: Any WBC
    • Age 1-9.99 years: WBC < 50,000/uL with:
    • Testicular leukemia
    • CNS leukemia (CNS3)
    • Steroid pretreatment.
    • White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy):
    • Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the the B-ALL stratum before the end of induction.
    • Patient has newly diagnosed B-ALL or MPAL (by World Health Organization [WHO] 2016 criteria) with >= 25% blasts on a bone marrow (BM) aspirate;
    • OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy;
    • OR A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.
    • Patient has newly diagnosed B-LLy Murphy stages III or IV.
    • Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.
    • Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.
    • Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.
    • All patients and/or their parents or legal guardians must sign a written informed consent.
    • All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.

    Exclusion Criteria:

    • Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group).
    • With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.
    • Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.
    • Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells.
    • Patients with acute undifferentiated leukemia (AUL) are not eligible.
    • For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional exclusion criteria apply:
    • T-lymphoblastic lymphoma.
    • Morphologically unclassifiable lymphoma.
    • Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.
    • Patients with known Charcot-Marie-Tooth disease.
    • Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.
    • Patients requiring radiation at diagnosis.
    • Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
    • Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Newark Beth Israel Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Randomized, Placebo-Controlled Trial Evaluating Memantine for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors. - NCT04939597

    To determine the efficacy, as measured by the slope of change of the Cogstate composite Z score from baseline to 12 months, of oral memantine administered for a period of 6 months, when compared to placebo, in children ages 4-18 receiving cranial or craniospinal radiotherapy for primary central nervous system tumors.

    View All Details
    • Protocol Number:
      112306

    • Principal Investigator:
      Peter Cole M.D.

    • Phase:
      Phase III

    • Scope:
      Local

    • Applicable Disease Sites:
      Brain and Nervous System

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Memantine

      • Contacts:

      • Rutgers University Prinicipal Investigator: Peter Cole M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • >= 4 and < 18 years at time of study entry
    • Patients must weigh 15 kg or greater at time of study entry
    • Primary central nervous system tumors that have not received prior cranial radiotherapy
    • Planned focal, cranial or craniospinal radiation treatment for a primary central nervous system tumor
    • The patient must have receptive and expressive language skills in English, French or Spanish since the neurocognitive function and quality of life (QOL) assessment instruments are available in these languages only
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
    • Age: 4 to < 6 years; Maximum serum creatinine (mg/dL): 0.8 male; 0.8 female
    • Age: 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 male; 1 female
    • Age: 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 male; 1.2 female
    • Age: 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 male; 1.4 female
    • Age: >= 16 years; Maximum serum creatinine (mg/dL): 1.7 male; 1.4 female
    • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
    • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L
    • Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
    • The patient must be able to undergo magnetic resonance imaging
    • All patients and/or their parents or legal guardians must sign a written informed consent
    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

    Exclusion Criteria:

    • Life expectancy of less than 18 months
    • Pre-existing conditions:
    • Any contraindication or allergy to study drug (memantine or placebo)
    • Intractable seizures while on adequate anticonvulsant therapy, defined as more than one seizure per month for the past 2 months or since initiating anticonvulsant therapy
    • History of neurodevelopmental disorder such as Down syndrome, Fragile X, William's Syndrome, intellectual disability (presumed intelligence quotient [IQ] < 70), etc
    • Co-morbid systemic illnesses, psychiatric conditions, social situations, or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or would limit compliance with the study requirements
    • Patients with a motor, visual, or auditory condition that precludes participation in computerized neurocognitive assessments
    • Patients with any medical condition or taking medications that lead to alterations of urine pH towards the alkaline condition (e.g., renal tubular acidosis, carbonic anhydrase inhibitors, sodium bicarbonate)
    • Personal history of prior cranial or craniospinal radiotherapy is not allowed
    • Note: Prior anti-cancer therapy including surgery, chemotherapy, targeted agents are allowed as per standard of care clinical treatment guidelines
    • Female patients who are pregnant are excluded since fetal toxicities and teratogenic effects have been noted for the study drug. A pregnancy test is required for female patients of childbearing potential
    • Lactating females who plan to breastfeed their infants
    • Sexually active patients of reproductive potential who do not agree to use an effective contraceptive method for the duration of their study participation

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
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