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  • A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma - NCT02954094

    Primary Aims 1. Establish a longitudinal observational cohort to understand the natural history and management of HCC, including the safety and outcomes of HCC treatment interventions utilized in usual clinical practice Secondary Aims 1. Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function 2. Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires 3. Establish a Biorepository Specimen Bank (BSB) Exploratory Aims 1. Investigate optimal type, duration, and sequence/combination of treatment interventions for HCC used in usual clinical practice 2. Perform biomarker analyses to identify potential markers predictive of response patterns or side effect profiles 3. Generate hypotheses that may lead to further investigations regarding natural course and treatment of HCC

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    • Protocol Number:
      001720

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

      • Contacts:

      • Archived - Rutgers Robert Wood Johnson Medical School Prinicipal Investigator: Vinod Rustgi MD, MBA

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Male or female patients, age ≥18 years 2. Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)

    Exclusion Criteria:

      1. Inability to provide written informed consent

    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 Basket Trial of Pembrolizumab in Patients with Advanced Solid Tumors and Genomic Instability. - NCT03428802

    To evaluate the response rate of pembrolizumab in patients with evidence of genomic instability classified as follows: 1) All solid tumors with POLE and POLD1 mutations 2) All solid tumors with BRCA1/2 mutations

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    • Protocol Number:
      051709

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Be willing and able to provide written informed consent/assent for the trial
    • Have a diagnosis of a tumor with evidence of genomic instability on Clinical Laboratory Improvement Amendments (CLIA) certified genomic testing, inclusive of mutations in POLE, POLD1 for arm 1 and in BRCA1 and BRCA2 for arm 2; in arm 2, enrollment of breast and ovarian histologies will be limited to a total of 10 patients
    • Have advanced cancer (metastatic, recurrent or locally advanced) and measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    • Be willing to provide archived tumor tissue; tissue from the most obtained core or excisional biopsy of a tumor lesion is preferred; 20 unstained slides are preferred but a minimum of 15 slides will be acceptable; if adequate tissue is not present the patient may consent to a newly obtained biopsy
    • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
    • Absolute neutrophil count (ANC) >= 1,500 /mcL, performed within 10 days of treatment
    • Platelets >= 100,000 / mcL, performed within 10 days of treatment
    • Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment), performed within 10 days of treatment
    • Serum creatinine =< 1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]), performed within 10 days of treatment
    • Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN, performed within 10 days of treatment
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases, performed within 10 days of treatment
    • Albumin >= 2.5 mg/dL, performed within 10 days of treatment
    • International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment
    • Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment
    • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
    • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
    • Male subjects should agree to abstinence or use of an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy

    Exclusion Criteria:

    • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
    • Has a diagnosis of immunodeficiency that requires receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment or has resulted in life threatening episodes previously regardless of current treatment
    • Has a known history of active TB (Bacillus tuberculosis)
    • Hypersensitivity to pembrolizumab or any of its excipients
    • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
    • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent
    • Note: Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
    • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
    • Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, or malignancies that have been inactive for three years or exceptionally indolent; any current diagnosis of second malignancy requires approval from principal investigator and sponsor
    • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 30 days prior to trial treatment; patients who had oligometastatic disease treated with stereotactic radiation or gamma knife therapy may receive treatment 14 days after therapy as long as they are not requiring steroids; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
    • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
    • Has known history of, or any evidence of active, non-infectious pneumonitis
    • Has an active infection requiring systemic therapy
    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
    • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
    • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
    • Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
    • Has received a live vaccine within 30 days of planned start of study therapy
    • Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
    • Tumors harboring non-hotspot POLE or POLD1 mutations that show clear evidence of microsatellite instability (MSI) will be excluded
    • Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)

    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 Dose Finding Study of CycloSam? (153Sm-DOTMP) to Treat Solid Tumor(s) in the Bone or Metastatic to the Bone (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewing s Sarcoma, and other solid tumor(s) to the bone all eligible)

    The primary objective of this study is: To determine the MTD of CycloSam?, given as a tandemly administered pair of doses to subjects with one or more solid tumor(s) in the bone or metastatic solid tumors to the bone that are visible on bone scan. The secondary objectives of this study are: To describe the toxicity and long-term effects of infusional CycloSam?; To assess the clinical response of solid tumors to the bone or metastatic to the bone to therapy with infusional CylcoSam?; To describe the distribution of absorbed doses delivered to each targeted lesion and the distribution of lesion equivalent uniform dose delivered to each subject; To observe overall survival and time to progression in subjects treated with infusional CycloSam?, and model any relationship between total absorbed dose and progression; To assess the extent of pain palliation using a visual analogue scale (VAS) in subjects treated with infusional CycloSam?.

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    • Protocol Number:
      052201

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site,Prostate,Breast,Lung

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      CycloSam (153Sm-DOTMP)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sanjay Goel
    • Rutgers Cancer Institute of New Jersey
  • A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors - NCT03845166

    The primary objective is: Determine the maximum tolerated dose (MTD) and/or recommended dose (RD) for further evaluation of XL092 when administered alone and in combination with ICIs to subjects with advanced solid tumors. The secondary objectives are: Evaluate the safety of XL092 when administered alone and in combination with ICIs through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs), including immune-related adverse events (irAEs), and adverse events of special interest (AESIs) Evaluate the plasma pharmacokinetics (PK) of XL092 and it potential metabolites following XL092 administration alone and in combination with ICI The exploratory objectives are: ORR as assessed by the Investigator per RECIST 1.1 Investigate the relationship between PK and selected or exploratory biomarkers, preliminary efficacy, and safety outcomes

    View All Details
    • Protocol Number:
      052209

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

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

    • Drugs Involved:
      Atezolizumab (MPDL3280A) XL092 Avelumab

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sanjay Goel

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Cytologically or histologically confirmed solid tumor that is inoperable locally advanced, metastatic, or recurrent.
    • Dose-escalation (single-agent and combination therapy): Subjects with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.
    • Expansion Cohort A (ccRCC): Subjects with previously treated advanced RCC with clear cell histology (including those with a sarcomatoid component) who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
    • Expansion Cohorts B and E (nccRCC): Subjects with previously treated advanced RCC with non-clear cell histology who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
    • Expansion Cohorts C and F (HR+ BC): Subjects with breast cancer that is hormone receptor positive (ER+ and/or PR+) and negative for human epidermal growth factor receptor 2 (HER-2) and who have radiographically progressed during or following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
    • Expansion Cohorts D and G (mCRPC): Subjects with metastatic CRPC (adenocarcinoma of the prostate). Neuroendocrine differentiation and other features permitted if adenocarcinoma is the primary histology.
    • Expansion Cohort H (CRC): Subjects with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum, KRAS/NRAS wild-type (confirmed via local testing report) and determined NOT to have microsatellite instability high (MSI-high) or mismatch repair deficient (dMMR) by local testing, who received the following standard of care chemotherapy regimens as prior therapy for metastatic CRC:
    • Fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-VEGF monoclonal antibody (bevacizumab)
    • Anti-EGFR monoclonal antibody (cetuximab or panitumumab)
    • BRAF inhibitor (in combination with cetuximab +/- binimetinib) for subjects with BRAF V600E mutations
    • Expansion Cohort I (UC, Maintenance Therapy): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who received first-line chemotherapy of gemcitabine + cisplatin and/or gemcitabine + carboplatin.
    • Expansion Cohort J (UC, ICI-refractory): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who progressed on or after PD-1/PD-L1 targeting ICI therapy.
    • Expansion Cohort K (UC, platinum-refractory): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who progressed on or after first-line platinum-based combination therapy.
    • Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1, with exception of Cohort I (UC, Maintenance Therapy).
    • Tumor tissue material:
    • Subjects in the non-biomarker cohort provide archival, if available, or fresh tumor tissue if it can be safely obtained.
    • Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
    • Adequate organ and marrow function.
    • Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception.
    • Female subjects of childbearing potential must not be pregnant at screening.

    Exclusion Criteria:

    • Prior treatment with XL092 (all cohorts), prior treatment with PD-L1/PD-1 targeting immune checkpoint inhibitor (Cohorts E, F, G, H, I, and K only), prior treatment with avelumab (Cohort J only), or prior treatment with regorafenib and/or TAS-102 (Cohort H only).
    • Receipt of any type of small molecule kinase inhibitor within 2 weeks before first dose of study treatment.
    • Receipt of any type of anticancer antibody, systemic chemotherapy, or hormonal anticancer therapy within 4 weeks before first dose of study treatment.
    • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
    • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.
    • Uncontrolled, significant intercurrent or recent illness.
    • Concomitant use of certain medications.
    • Corrected QT interval calculated by the Fridericia formula (QTcF) > 450 ms for males and > 470 ms for females. Single ECGs are no longer permitted.
    • Pregnant or lactating females.
    • Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.

    Additional Exclusion Criteria for XL092 + Atezolizumab Combination Therapy Cohorts ONLY:

    • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.
    • Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.

    Additional Exclusion Criteria for XL092 + Avelumab Combination Therapy Cohorts ONLY:

    • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
    • Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.

    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 First-in-Human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects with Advanced Solid Tumors. - NCT04485013

    Primary Objective: To assess safety and tolerability of increasing dose levels of TTX-080 in successive cohorts of subjects with advanced solid tumors to identify the maximum tolerated dose (MTD) or maximum administered dose and select the recommended Phase 2 dose (RP2D)/schedule. Secondary Objectives(s): (1) To characterize the single-dose and/or multiple-dose pharmacokinetics (PK) of TTX-080 following intravenous (IV) administration in subjects with advanced solid tumors. (2) To evaluate the immunogenicity of TTX-080 in subjects with advanced solid tumors. (3) To evaluate the preliminary antitumor activity of TTX-080 in subjects with advanced solid tumors. Exploratory Objective: To assess the effects of TTX-080 on pharmacodynamic biomarkers relating to mechanism of action and immune responses.

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    • Protocol Number:
      052006

    • Principal Investigator:
      Ryan Stephenson

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      TTX-080 Pembrolizumab (MK-3475) CETUXIMAB

      • Contacts:

      • Rutgers University Prinicipal Investigator: Ryan Stephenson

    Read Inclusion & Exclusion Criteria

    Abbreviated Inclusion Criteria:

      1. Subject with histological diagnosis of advanced/metastatic cancer 2. Age 18 years or older, is willing and able to provide informed consent 3. Evidence of measurable disease 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 AND life expectancy of at least 12 weeks

    Abbreviated Exclusion Criteria:

      1. History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody 2. Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study 3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy 4. History of severe autoimmune disease 5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

    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 multi-center open-label, phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ICP-192 in patients with advanced solid tumors and FGF/FGFR gene alterations. - NCT04565275

    Study Objectives Phase I: Dose Escalation Primary Objectives To evaluate the safety and tolerability of different doses of ICP-192 in patients with advanced solid tumors To determine Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for ICP-192 Secondary Objectives: To characterize the pharmacokinetics (PK) of ICP-192 in patients with solid tumors To assess pharmacodynamics (PD) and the relationship between PK and PD of ICP-192 in patients with advanced solid tumors To evaluate the preliminary anti-tumor activities of ICP-192 if the data allowed Phase II: Dose Expansion Primary Objectives: To evaluate the preliminary anti-tumor activities of ICP-192 in patients with cholangiocarcinoma or head and neck cancer with FGF/FGFR gene alterations Secondary Objectives: To evaluate the safety and tolerability of ICP-192 in patients with cholangiocarcinoma or head and neck cancer To characterize the PK of ICP-192 in patients with cholangiocarcinoma or head and neck cancer To analyze the response rate in biomarker-specific subgroup

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    • Protocol Number:
      052205

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      ICP-192

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sanjay Goel

    Read Inclusion & Exclusion Criteria

    Major Inclusion Criteria

      Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participate voluntarily, sign informed consent, and follow the study treatment plan and scheduled visits; 2. Phase I: Patients with histologically or cytologically confirmed unresectable or metastatic advanced malignant solid tumors who have progressed under standard treatment or recurred after or were intolerant to all standard treatment regimens, or have no standard treatment available; 3. Phase II: patients with histologically or cytologically confirmed unresectable or metastatic urothelial carcinoma or cholangiocarcinoma, who have progressed or recurred after or were intolerant to first-line chemotherapy, or have progressed/relapsed within 12 months after neoadjuvant /adjuvant chemotherapy; 4. Phase II: Existing test reports have confirmed the FGFR gene alteration or the central laboratory has detected the FGFR gene alteration. 5. Age ≥18 years old; 6. At least one measurable lesion according to the Response Evaluation Criteria of Solid Tumor, version 1.1 (RECIST 1.1); 7. ECOG performance status of 0-1; 8. Life expectancy for more than 3 months; Must have adequate organ function Major

    Exclusion Criteria

      Participants are excluded from the study if any of the following criteria apply: 1. Have previously been treated with selective pan-FGFR molecular inhibitors or antibody drugs, except for the FGFR4 selective inhibitors; 2. Within 2 weeks before the first dose of study drug, the subject's phosphate level continuing to exceed the ULN despite medical treatment; 3. Patients with clinically significant gastrointestinal dysfunction 4. Has known central nervous system metastases; 5. Has a history of or currently uncontrolled cardiovascular diseases 6. History of organ transplantation or a history of allogeneic hematopoietic stem cell transplantation; 7. Current evidence of corneal or retinal abnormalities that may increase eye toxicity; 8. Active hepatitis B virus active hepatitis C, or HIV infection; 9. Has not recovered from reversible toxicity of prior anti-tumor therapy 10. Pregnant or lactating women, as well as women with childbearing potential who are unwilling or unable to perform contraception from the screening to 6 months after the last study drug administration; and fertile men who are unwilling or unable to perform contraception from screening to 3months after the last study drug administration 11. Other conditions considered by the investigator to be inappropriate for participation in this study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

    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 Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer (ECLIPSE). - NCT05204927

    Primary Objective: To prospectively assess the efficacy of 177Lu-PSMA-I&T on the improvement of radiographic progression-free survival (rPFS) as determined by PCWG3-modified RECIST 1.1 in men with metastatic Castration-Resistant Prostate Cancer (mCRPC) compared to standard of care hormone therapy. Secondary Objectives: To assess if 177Lu-PSMA-I&T improves overall survival (OS) in patients with mCRPC compared to those treated with standard of care hormone therapy. Other Secondary Objectives: 1. To assess the time to the second radiographic progression event in participants who crossover from standard of care hormone therapy to treatment with 177Lu-PSMA-I&T (rPFS2). 2. To assess the time to progression as determined by the investigator in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy. 3. To assess the time to progression 2 as determined by the investigator in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy. 4. To evaluate the change in baseline PSA50 response rate following 177Lu-PSMA-I&T radioligand therapy compared to standard of care hormone therapy. 5. To assess the time to first symptomatic skeletal event (SSE) following treatment with 177Lu-PSMA-I&T radioligand therapy compared to standard of care hormone therapy. 6. To evaluate the time to radiographic soft tissue progression in participants treated with 177Lu-PSMA-I&T compared to those treated with standard of care hormone therapy. 7. To evaluate the time to chemotherapy in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy. 8. To assess any improvement in the quality of life measurements in participants treated with 177Lu-PSMA-I&T compared to standard of care hormone therapy.

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    • Protocol Number:
      082107

    • Principal Investigator:
      Tina Mayer M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Prostate

    • Therapies Involved:
      Radiotherapy Hormonal Therapy

    • Drugs Involved:
      Abiraterone

      • Contacts:

      • Rutgers University Prinicipal Investigator: Tina Mayer M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Male 18 years or older able to understand and provide signed written informed consent. 2. Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component. 3. Progressive disease by one or more of the following criteria: 1. Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart with a minimum start value of >2 ng/mL. 2. Progression of measurable disease (RECIST 1.1) or presence of at least two new bone lesions (PCWG3 criteria). 4. Previous treatment with next-generation androgen receptor (AR)-directed therapy (e.g. abiraterone, enzalutamide, apalutamide, darolutamide). 1. Must have received no more than one previous AR-directed therapy. 2. Must have been administered ARAT (abiraterone, enzalutamide, darolutamide, or apalutamide) in the castration-sensitive or castration-resistant setting. 3. Must have progressed while on ARAT. 5. PSMA-PET scan (e.g., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by central reader. 6. Effective castration with serum testosterone level of <50 ng/dL and plan to continue with chronic medical or surgical castration. 7. Ability to attend required study visits and return for adequate follow-up, as required by this protocol. 8. Patients with HIV that are healthy and with a low risk of acquired immune deficiency syndrome related outcomes may participate in the trial at the investigators' discretion. 9. Patients with HBV and HCV may also participate if symptoms are sufficiently managed. 10. Life expectancy of at least 6 months as assessed by investigator. 11. Willing to initiate ARAT therapy determined by investigator. 12. For patients who have partners of childbearing potential: The patient and/or partner must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 6 months after the last study drug administration.

    Exclusion Criteria:

      1. Prior treatment with radioligand therapy including other lutetium-labeled compounds. 2. Prior treatment with radium-223 (Xofigo) within the past 12 weeks. 3. Prior chemotherapy treatment for castration-sensitive or castration-resistant prostate cancer (docetaxel or cabazitaxel). 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2 5. Patients with known HRR gene-mutation who have not been previously treated with olaparib or rucaparib. 6. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. 7. Inadequate organ and bone marrow function as evidenced by: 1. Hemoglobin < 8 g/dL. 2. Absolute neutrophil count < 1.5 x 109/L. 3. Platelet count < 100 x 109/L. 4. AST/SGOT and/or ALT/SGPT > 3.0 x ULN. 5. Total bilirubin > 2 x ULN unless patient has known Gilbert's syndrome and then may be 3 x ULN. 6. Creatinine clearance (CrCl) < 50 mL/min based on the Cockcroft-Gault equation. 7. Albumin ≤ 2.75 g/dL 8. Patients who undergo a transfusion for the sole purpose of meeting eligibility for this trial will be excluded. 9. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol. 10. Use of an investigational therapeutic drug within the last 4 weeks prior to start of study treatment or scheduled to receive one during the study period. 11. Known CNS metastasis unless received therapy, asymptomatic and neurologically stable. 12. Patients receiving zoledronic acid for bone-targeted therapy must be on stable dose for 4 weeks prior to randomization. 13. Major surgery within 30 days of randomization as determined by the Investigator. 14. Patients with active significant cardiac disease defined by any of the following: 1. New York Heart Association class 3 or 4 congestive heart failure within 6 months of signing the ICF unless treated with improvement. 2. Current diagnosis of electrocardiogram abnormalities with significant cardiac arrhythmias 3. History of long QT syndrome or know history of Torsades de Pointe 4. History of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months of ICF signature 15. Participants with symptomatic cord compression or clinical/radiological findings indicating impending spinal cord compression 16. Patients with a superscan seen on baseline bone scan as determined by investigator. 17. Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer 18. Previous use of G-CSF for persistent neutropenia after standard of care treatment. 19. Participants who have a pregnant partner or are capable of fathering a child and who are unwilling to take precautions to prevent potential harm to the fetus or prevent pregnancy. 20. Participants with active Covid19. Recovered patients may be included when completely recovered (no symptoms at least 28 days before study medication and a negative Covid test within 72 hours).

    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 Multi-Level Investigation of US Indoor Tanning Policy Enactment, Implementation, Compliance, Impact, and Economics.

    1. Identify factors contributing to adoption or rejection of indoor tanning legislation through document analysis of indoor tanning bills and key informant interviews. 2. Assess indoor tanning law implementation. 3. Investigate important economic factors relevant to Indoor tanning law maintenance.

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    • Protocol Number:
      132005

    • Principal Investigator:
      Carolyn Heckman Ph.D.

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Melanoma, Skin

      • Contacts:

      • Rutgers University Prinicipal Investigator: Carolyn Heckman Ph.D.
    • Rutgers Cancer Institute of New Jersey
  • A Multicenter, Double-Blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy. - NCT05239728

    Primary Objective: To compare disease-free survival (DFS) as assessed by investigator for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. Hypothesis (1): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS. Secondary Objectives: - To compare overall survival (OS) for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. Hypothesis (2): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to OS. - To compare the safety and tolerability profiles for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. - To compare measures of disease recurrence-specific survival (DRSS) as assessed by the investigator, in participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab. - To evaluate change from baseline in health-related quality of life (HRQoL) and symptoms using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life 30 Questionnaire (QLQ-C30) and the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-related Symptoms (FKSI-DRS).

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    • Protocol Number:
      082106

    • Principal Investigator:
      Biren Saraiya M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Kidney

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Belzutifan (MK-6482)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Biren Saraiya M.D

    Read Inclusion & Exclusion Criteria

    The main inclusion and exclusion criteria include but are not limited to the following:

    Inclusion Criteria:

    • Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
    • Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading: 1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0 2. High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0 3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤2 years from nephrectomy (metachronous)
    • Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
    • Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization
    • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization.
    • Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo
    • Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occurs last
    • Has adequate organ function

    Exclusion Criteria:

    • Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization
    • Has a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
    • Has clinically significant cardiovascular disease within 6 months from first dose of study intervention
    • Has other clinically significant disorders such as: serious active nonhealing wound/ulcer/bone fracture; requirement for hemodialysis or peritoneal dialysis
    • Has preexisting brain or bone metastatic lesions
    • Has received prior systemic therapy for RCC
    • Has received prior radiotherapy for RCC
    • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines are allowed
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
    • Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
    • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy is allowed
    • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
    • Has an active infection, requiring systemic therapy
    • Has a known history of human immunodeficiency virus (HIV) infection, a known history of Hepatitis B or known active Hepatitis C virus infection
    • Has had an allogenic tissue/solid organ transplant

    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 Multicenter, Open Label, Phase III Extension Trial to Study the Long-Term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial. - NCT03486873

    Primary Objective: To estimate the OS. Secondary Objectives: - To estimate the DOR and DOCR per evaluation criteria used in the parent trial by investigator assessment for participants who have received or are receiving First Course Phase trial treatment with pembrolizumab or a pembrolizumabbased combination. - To evaluate the safety and tolerability of pembrolizumab or a pembrolizumab-based combination in participants who receive it as First or Second Course Phase trial treatment.

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    • Protocol Number:
      051804

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready
    • Currently receiving pembrolizumab or in a follow-up phase Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:
    • Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase
    • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Demonstrates adequate organ function
    • Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
    • A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.

    Exclusion Criteria:

    • There are no exclusion criteria to participate in MK-3475-587. Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:
    • Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
    • Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase
    • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
    • Has known active central nervous system metastases and/or carcinomatous meningitis
    • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
    • Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease
    • Has an active infection requiring systemic therapy
    • Has a known history of human immunodeficiency virus (HIV) infection.
    • Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.
    • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
    • Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
    • Has hepatic decompensation (Child-Pugh score >6 [class B and C])
    • Has uncontrolled thyroid dysfunction
    • Has uncontrolled diabetes mellitus
    • Has had an allogeneic tissue/solid organ transplant
    • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)

    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 Multicenter, Open-Label Study with a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients with Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy. - NCT04762069

    Primary Objective: To assess the effect of berubicin compared with lomustine on overall survival(OS) in adult patients with GBM (WHO Grade IV) that has recurred after standard initial therapy.

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    • Protocol Number:
      142101

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Brain and Nervous System

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Berubicin LOMUSTINE

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Michael E. Salacz MD

    Read Inclusion & Exclusion Criteria

    Patients will be eligible for the study if they meet all of the following inclusion criteria and none of the exclusion criteria.

    Inclusion criteria

      1. Written informed consent from the patient or their legally authorized representative (LAR) prior to any study-related procedure, and willing and able to comply with the protocol and aware of the investigational nature of this study. 2. At least 18 years of age. 3. KPS score of ≥ 60 4. A confirmed GBM diagnosis must be based on local review of tumor tissue from the initial biopsy, surgery, or re-resection. A formal pathology report confirming GBM is acceptable. It is not a requirement for slides to be sent to a central reviewer. 5. Recurrent or progressive GBM as evaluated by central review applying RANO criteria on contrast MRI scans of the Baseline/Screening MRI scan obtained up to six weeks prior to C1D1 and a historical scan taken before the Baseline/Screening scan that meets at least 1 of the following criteria: 1. In the case of measurable disease, progression will be documented by ≥ 25% increase in the sum of the perpendicular diameter products (SPDPs) of the measurable contrast-enhancing (target) lesions or any new measurable lesions. 2. If the SPDPs cannot be reliably estimated due to the lesion's complex conspicuity, shape, and contrast enhancement pattern, the volume of all measurable and non-measurable lesions may be used instead, applying the same threshold (≥ 25% increase) to confirm disease progression. 3. In the case of non-measurable lesions in the historical scan, any transformation into measurable lesions (≥10 mm in both maximum perpendicular diameters) in the Baseline/Screening scan will be evidence of progression. 4. If there are only non-measurable (non-target) lesions in the Baseline/Screening scan, additional lesions/sites will be considered evidence of progression based on the historical scan. Patients with new cerebrospinal fluid (CSF) seeding will not be considered eligible. 5. If historical scans are unavailable, a radiology report of a scan taken before the Baseline/Screening scan documenting the SPDPs from a previous scan of the enhancing disease or its volume can be used by the central reviewer to assess eligibility if it demonstrates the quality standards and acquisition guidelines required. 6. If the scan obtained during standard of care (prior to initiation of formal clinical screening and patient enrollment) is being used as the Baseline/Screening scan and does not entirely conform to central reader quality standards and acquisition guidelines (ie, artifacts or missing sequences), this can be used for the purpose of inclusion if the central reader in discussion with the sponsor and PI agree it provides evidence based on standard clinical practices of recurrence or progression. 7. Patients at first progression who are treated by re-resection or biopsy to confirm progression do not require measurable disease at their post-operative screening scan as their Baseline/Screening scan. These patients must be medically stable after the procedure as assessed by the PI and have the Baseline/Screening scan available by 7 days before starting treatment. 6. The tumor is localized supratentorially with no leptomeningeal (local or distant), spinal or CSF metastases, and no ventricular invasion (explicit documentation of the disease progression that would be problematic in evaluating the efficacy of this drug). 7. O[6] methylguanine-DNA methyltransferase (MGMT) methylation status must be available; results of routinely used methods for MGMT methylation testing (eg, methylation-specific polymerase chain reaction or quantitative polymerase chain reaction) are acceptable. 8. No more than 1 prior line of treatment (eg, surgery followed by radiation with concomitant chemotherapy, followed by adjuvant chemotherapy is considered as 1 line of treatment). In addition, treatment with tumor treating fields (TTFields; Optune) is acceptable if provided as first line therapy prior to progression or recurrence of disease. 9. A second debulking surgery, additional radiation or gamma knife surgery during the first line treatment or after progression, and for which the investigator does not suspect pseudoprogression is acceptable, as long as no chemotherapy or immunotherapy has been provided. 10. Recovery from toxicity/side effects of all prior therapy to Grade 1 or less, subject to the investigator's discretion, except for alopecia; the following time intervals from previous treatments are required to be eligible: 1. 12 weeks from the completion of radiation (to reduce risk of pseudoprogression), unless progression is confirmed by biopsy 2. 4 weeks from the end of any previous of chemotherapy 3. 2 weeks from tumor biopsy if wound completely healed 4. 4 weeks from any major surgery (maximal debulking surgery, either gross total resection or partial resection), gamma knife surgery or significant traumatic injury. Any surgery incisions or wounds must be completely healed 11. A stable or decreasing dose of corticosteroids (or none) for brain edema for at least 5 days prior to baseline MRI and enrollment in the study to document disease progression such that changes in the MRI are not related to the use of corticosteroids. 12. Eligible for chemotherapy based on adequate bone marrow function and organ function within 2 weeks of study treatment as defined by the following laboratory guidelines, subject to the investigator's discretion: 1. Hematopoietic function: total white blood cell (WBC) count ≥3 × 103/µL, absolute neutrophil count (ANC) ≥1.5 × 10³/µL, platelet count ≥75 × 10³/µL, hemoglobin ≥10 g/dL 2. Hepatic function: bilirubin ≤1.5 × × the upper limit of normal (ULN) (excluding Gilberts Syndrome, for which bilirubin must be ≤4 × ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3 × ULN, and alkaline phosphatase ≤2.5 × ULN 3. Renal function: serum creatinine ≤1.5 × ULN or for patients with creatinine levels above the ULN, estimated creatinine clearance of ≥60 mL/min, calculated using the Cockcroft-Gault equation35 4. Activated partial thromboplastin time (aPTT) ≤1.5 × ULN 13. Women of childbearing potential must agree to practice a highly effective method of contraception beginning at least 28 days before the start of treatment until at least 6.25 months after the last dose of study drug. Male study patients and their female sexual partners of childbearing potential must agree to practice a highly effective method of contraception starting from the time of informed consent until at least 3.5 months (no less than 104 days) after the last dose of study drug. 1. A woman of childbearing potential is defined as a woman who is not permanently sterilized or postmenopausal. Postmenopausal is defined as 12 months with no menses without an alternative medical cause. 2. Women of childbearing potential must have a negative serum or urine pregnancy test at Screening. 3. A highly effective method of birth control is defined as one which results in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. For patients using a hormonal contraceptive method, information regarding all medications being administered to the patient and their potential effects on the contraceptive should be addressed. 14. Patients with prior malignancies must be disease-free for ≥5 years. Curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; or prostate cancer as well as benign tumors that will not interfere with the treatment plan at the time of screening are allowed.

    Exclusion Criteria

      1. Unable or not willing to comply with the protocol regulations. 2. Any additional chemotherapy (including but not limited to TMZ or immunotherapy) for recurrent or progressive GBM after a first line treatment. 3. Prior treatment with bevacizumab. 4. Prior treatment with lomustine. 5. Known to have an IDH mutation prior to enrollment 6. Screening/Baseline MRI showing a mass effect defined as significant compression of the ventricular system and/or a midline shift with associated clinical symptoms deemed inappropriate for the patient to enter a clinical trial. If there is otherwise asymptomatic compression and/or midline shift and the patient fulfills all other criteria, these patients are considered eligible. 7. Any condition (medical, social, psychological) that would prevent adequate information and follow-up, including but not limited to clinically relevant psychiatric disorders, legal incapacity, dementia, adults protected by law or altered mental status. 8. Presence of poorly controlled seizures, defined as occurring despite SOC or requiring hospitalization. 9. Prior anthracycline cumulative dose more than 550 mg/m2. 10. Heart disease: 1. LVEF <50% 2. Unstable angina 3. CHF with New York Heart Association (NYHA) classification of 3 or 4 4. Patients with baseline QT/QTc interval >480 msec, a history of additional risk factors for torsades de pointes (TdP) (eg, heart failure, hypokalemia, family history of long QT syndrome) and using concomitant medications that significantly prolong the QT/QTc interval 5. History of myocardial infarction within 12 months of enrollment 6. Severe arrhythmia not controlled by medication 11. Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg and/or diastolic BP >100 mmHg) sustained over 2 measurements. 12. Known to be positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV), human immunodeficiency virus (HIV), COVID-19 (currently positive at time of screening), or any other acute viral, bacterial, or fungal infection (testing not required unless symptomatic or suspected disease). 13. Patients with any other uncontrolled intercurrent medical conditions, including but not limited to diabetes mellitus or chronic obstructive pulmonary disease that have not been well controlled by medical management over the prior 3 months are ineligible unless approved by the sponsor. 14. Women who are lactating or breastfeeding

    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 Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRC1 Carriers. SOROCK - NCT04251052

    Primary Objective: - To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germline mutations. Secondary Objectives: - To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the FACT-ES subscale compared to women in the BSO arm. To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL), sexual dysfunction (FSFI), and cancer distress (IES) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients. - To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice. - To assess adverse events, graded using CTCAE v5.0.

    View All Details
    • Protocol Number:
      102005

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Women 35-50 years of age, inclusive
    • Patients who have declined or elected to defer risk-reducing salpingo-oophorectomy (RRSO) after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers (for the BLS with delayed oophorectomy arms) or patients who are undergoing RRSO (for the RRSO arm)
    • At least one intact ovary and fallopian tube is in situ at the time of counseling and consent. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one intact ovary and tube are present
    • Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient herself. Documentation of the result is required
    • Premenopausal; defined as < 12 months of amenorrhea. However, for those patients with >= 12 months of amenorrhea who may be pre-menopausal or patients with a prior hysterectomy with at least one retained ovary/tube, levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and in the premenopausal range per local institutional standards will be acceptable. Concurrently planned hysterectomy with salpingectomy for the BS group or with BSO for the BSO group is permitted
    • Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

    Exclusion Criteria:

    • Women with a history of any prior cancer who have received chemotherapy within the past 12 months, hormonal therapy in the past 90 days, or radiotherapy to abdomen or pelvis at any prior time
    • Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma
    • Patients medically unfit for the planned surgical procedure
    • Patients with abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days
    • An abnormal TVUS is defined as morphologic or structural variations suspicious for ovarian malignancy or complex cystic lesions (simple cysts < 5 cm in maximal diameter are not exclusionary)
    • An abnormal CA-125 is defined as a level > 50 U/ml in this study population of premenopausal women if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40 U/ml for premenopausal women who are current users of oral contraceptives
    • Women who are currently pregnant or plan to become pregnant in the future

    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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