11 results
  • 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.

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    • 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
  • A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors. - NCT03067181

    The aim of this study for low and standard risk germ cell tumor (GCT) patients is to minimize toxicity by reducing therapy while maintaining current survival rates. The trial will eliminate chemotherapy for low risk patients who are likely cured with surgery and will observe the salvage rates among those who recur.

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    • Protocol Number:
      111702

    • Principal Investigator:
      Archana Sharma DO

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site,Prostate,Ovary

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BLEOMYCIN CARBOPLATIN CISPLATIN ETOPOSIDE

      • Contacts:

      • Rutgers University Prinicipal Investigator: Archana Sharma DO

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])
    • Standard risk 1: Patient must be < 11 years of age at enrollment
    • Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment
    • Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment
    • Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; all ages
    • Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
    • Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
    • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11
    • Standard risk 2 (SR2)
    • Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
    • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25
    • Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
    • Notes:
    • IGCCC criteria only apply to SR2 patients with a testicular primary tumor
    • Use post-op tumor marker levels to determine IGCCC risk group
    • Stage 1 seminoma patients are not eligible for the standard risk arms of the study
    • For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor
    • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
    • Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)
    • Adequate renal function defined as:
    • 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): (mg/dL)
    • 1 month to < 6 months male: 0.4 female: 0.4
    • 6 months to < 1 year male: 0.5 female: 0.5
    • 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
    • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
    • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L) (within 7 days prior to enrollment)
    • Peripheral absolute neutrophil count (ANC) >= 1,000/mm^3 (within 7 days prior to enrollment) AND
    • Platelet count >= 100,000/mm^3 (within 7 days prior to enrollment)
    • Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment
    • Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate
    • >= 11 and < 25 years old at enrollment
    • Able to fluently speak and read English
    • Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
    • Followed for cancer or survivorship care at one of the following institutions:
    • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    • Dana Farber/Harvard Cancer Center
    • Hospital for Sick Children
    • Children's Hospital of Eastern Ontario
    • Oregon Health and Science University
    • Seattle Children's Hospital
    • Yale University

    Exclusion Criteria:

    • Patients with any diagnoses not listed including:
    • Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
    • Pure dysgerminoma
    • Pure mature teratoma
    • Pure immature teratoma COG stage I, grade I
    • Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) >= 1000 ng/mL
    • Pure immature teratoma COG stage II - IV or FIGO stage IC to IV
    • "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or
    • Primary central nervous system (CNS) germ cell tumor
    • Germ cell tumor with somatic malignant transformation
    • Spermatocytic seminoma
    • Patients must have had no prior systemic therapy for the current cancer diagnosis
    • Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial)
    • Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
    • 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; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
    • Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])

    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, Double-Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma (FLORA-5). - NCT04498117

    Primary: To determine the efficacy by progression free survival (using investigator assessment of scans according to RECIST v1.1) of oregovomab compared to placebo when administered with background chemotherapy (paclitaxel/carboplatin) to subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery Secondary: - To determine the efficacy by overall survival of oregovomab compared to placebo when administered with background chemotherapy (paclitaxel/carboplatin) to subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery. - To assess the safety and tolerability of oregovomab compared to placebo when administered with background chemotherapy (paclitaxel/carboplatin) to subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery. - To evaluate the effects of treatment with oregovomab compared to placebo when administered with background chemotherapy (paclitaxel/carboplatin) on Health-related Quality of Life(HRQoL) as assessed by trial outcome index (TOI) of the Functional Assessment of Cancer Therapy Ovarian (FACT-O) and 3 additional questions from the NFOSI-18 in subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery.

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    • Protocol Number:
      102103

    • Principal Investigator:
      Aliza Leiser

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Other Female Genital,Ovary

    • Therapies Involved:
      Surgery Chemotherapy single agent systemic

    • Drugs Involved:
      Oregovomab

      • Contacts:

      • Rutgers University Prinicipal Investigator: Aliza Leiser

    Read Inclusion & Exclusion Criteria

    Major Inclusion Criteria:

      1. Adults 18 years old or older. 2. Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease. 3. Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.). 4. Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator). Debulking surgery must be optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor). 5. Preoperative serum CA- 125 levels ≥ 50 U/mL. 6. Adequate bone marrow function: 1. Absolute neutrophil count (ANC) greater than or equal to 1,500/µL 2. Platelets greater than or equal to100,000/µL 3. Hemoglobin greater than or equal to 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment). 7. Adequate liver function: 1. Bilirubin < 1.5 times upper limit normal (ULN) 2. Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN 3. Albumin >3.5 g/dL 8. Adequate renal function: a. Creatinine less than or equal to1.5 times ULN 9. ECOG Performance Status of 0 or 1.

    Major Exclusion Criteria:

      1. BRCA1 or BRCA2 germline gene mutation test result with: 1. Positive, ambiguous or inconclusive result available within 28 days prior to starting study treatment, or 2. Known BRCA1 and BRCA2 somatic mutations, and known positive germline, or 3. Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy. 2. Subjects with mucinous adenocarcinoma and low- grade adenocarcinoma. 3. Female subjects who are lactating and breastfeeding, or have a positive serum pregnancy test within 7 days prior to the first dose of study treatment (C1D1 for Cohort 1 or C4D1 for Cohort 2). 4. Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing spondylitis requiring active disease modifying treatment. 5. Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin. 6. Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc. (see Appendix G). 7. Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent, with the exception of inhalers or those on a pre-planned steroid taper. (Note: Premedication with corticosteroids per institutional standard of care is allowed.) 8. Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia. 9. Anticipated treatment with any other anti-cancer medications, including bevacizumab, poly (ADP- ribose) polymerase (PARP) inhibitors, or any investigational agent(s) during the 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.

    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator s Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7). - NCT05092360

    Primary Objective: To evaluate the antitumor activity of nemvaleukin alfa ( nemvaleukin , ALKS 4230) in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancer. Secondary Objectives: - To evaluate the antitumor activity of nemvaleukin in combination with pembrolizumab as compared with chemotherapy. - To evaluate the safety of nemvaleukin in combination with pembrolizumab as compared with chemotherapy.

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    • Protocol Number:
      102203

    • Principal Investigator:
      Aliza Leiser

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

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

    • Drugs Involved:
      PACLITAXEL LIPOSOMAL DOXORUBICIN Nemvaleukin Alfa MK-3475 (Pembrolizumab) TOPOTECAN GEMCITABINE

      • Contacts:

      • Rutgers University Prinicipal Investigator: Aliza Leiser

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patient is female and ≥18 years of age.
    • Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous, endometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal cancer.
    • Patient has platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically on or after their most recent line of anticancer therapy.
    • Patient must have received at least 1 prior line of systemic anticancer therapy in the platinum sensitive setting, and no more than 5 prior lines of systemic anticancer therapy in the platinum-resistant setting. Patient must have received at least 1 line of therapy containing bevacizumab.
    • Patient has at least one measurable lesion that qualifies as a target lesion based on RECISTv1.1.
    • Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifying archival tumor tissue.

    Exclusion Criteria:

    • Patient has primary platinum-refractory disease or primary platinum resistance, defined as disease progression during first-line platinum-based therapy (refractory) or disease progression <3 months after completion of first-line platinum-based therapy (resistant).
    • Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcoma subtype.
    • Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumor with low malignant potential (ie, borderline or low-grade serous tumor).
    • Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis) of ≥500 mL within 6 weeks of first dose of study drug.
    • Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof.
    • Patient has prior exposure to any anti-PD1/PD-L1 therapy.

    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.

    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumors. - NCT02582697

    1. To determine if accelerated BEP (Bleomycin, Etoposide, cisPlatin) is superior to standard BEP as first-line chemotherapy for intermediate and poor-risk metastatic GCTs. 2. To compare the two treatment arms with respect to: a) Progression-free survival (disease progression or death) b) Response following treatment completion (protocol-specific response criteria) c) Adverse events (worst grade according to NCI CTCAE v4.03) d) Delivered dose-intensity of chemotherapy (Relative to standard BEP) e) Overall survival (death from any cause)

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    • Protocol Number:
      111904

    • Principal Investigator:
      Richard Drachtman M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Other Female Genital,Other Male Genital

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      IFOSFAMIDE Pegfilgrastim MESNA ETOPOSIDE CISPLATIN

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Age ≥ 11 years and ≤ 45 years on the date of randomisation 2. Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently 3. Primary arising in testis, ovary, retro-peritoneum, or mediastinum 4. Metastatic disease or non-testicular primary 5. Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information). 6. Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L 7. Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN 8. Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to the Cockcroft-Gault formula, unless calculated to be < 60 ml/min or borderline in which case GFR should be formally measured, eg. with EDTA scan 9. ECOG Performance Status of 0, 1, 2, or 3 10. Study treatment both planned and able to start within 14 days of randomisation. 11. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments 12. Able to provide signed, written informed consent

    Exclusion Criteria:

      1. Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence) 2. Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient has non-seminoma and poor prognosis by IGCCC criteria in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). In these instances acceptable regimens include cisplatin 20 mg/m^2 days 1-2 and etoposide 100 mg/m^2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m^2 days 1-2; or baby-BOP. Patients must meet all other inclusion and exclusion criteria at the time of registration. Additionally participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy. 3. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin 4. Significant co-morbid respiratory disease that contraindicates the use of bleomycin 5. Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus 6. Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety 7. Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy. 8. Known allergy or hypersensitivity to any of the study drugs 9. Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse The above inclusion and exclusion criteria will apply to stage 1 (n=150) and stage 2 (n=500 including stage 1) of the study. All sites will participate in both stages of the study with the exception of the Children's Oncology Group who will be participate in stage 1 only.

    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 Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer. - NCT05446870

    Primary Objective: Among patients with detectable ctDNA at baseline, to evaluate whether the reduction from baseline in circulating tumor DNA at Cycle 3 is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) chemotherapy than in those receiving pembrolizumab + SOC. Secondary Objectives: - Among patients with detectable ctDNA at baseline, to evaluate the association between neoadjuvant ctDNA at Cycle 3 from baseline and surgical outcomes. - To estimate the difference in pCR and CRS following neoadjuvant treatment between arms. - To evaluate the safety and tolerability of MK-4830 administered with pembrolizumab and chemotherapy.

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    • Protocol Number:
      102201

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Pembrolizumab (MK-3475) CARBOPLATIN PACLITAXEL Avastin MK-4830

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

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

    Inclusion Criteria:

    • Has histologically-confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV HGSOC, primary peritoneal cancer, or fallopian tube cancer.
    • Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant and adjuvant setting.
    • Is a candidate for interval debulking surgery.
    • Is able to provide archival tissue or newly obtained core, incisional, or excisional biopsy of a tumor lesion.
    • Has adequate organ functions.

    Exclusion Criteria:

    • Has a non-HGSOC histology.
    • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
    • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
    • Has received prior treatment for any stage of OC, including radiation or systemic anticancer therapy.
    • Planned or has been administered intraperitoneal chemotherapy as first-line therapy.
    • Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death 1 ligand 1 (PD-L1), anti-programmed cell death 1 ligand 2 (PD-L2), anti-immunoglobulin-like transcript 4 (ILT4), or anti-human leukocyte antigen (HLA)-G agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
    • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
    • 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 the first dose of study medication.
    • Has known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis.
    • Has severe hypersensitivity to pembrolizumab, carboplatin, paclitaxel (or docetaxel, if applicable), Avastin or biosimilar (if using) and/or any of their excipients.
    • Has an active autoimmune disease that has required systemic treatment in past 2 years.
    • Has an active infection requiring systemic therapy.
    • Has a known history of human immunodeficiency virus (HIV) infection.
    • Has a known history of hepatitis B or known active hepatitis C virus infection.
    • Has received colony-stimulating factors within 4 weeks prior to receiving study intervention on Day 1 of Cycle 1.
    • Has had surgery <6 months prior to Screening to treat borderline ovarian tumors, early-stage OC, or early-stage fallopian tube cancer.
    • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
    • Has current, clinically relevant bowel obstruction.
    • Has a history of hemorrhage, hemoptysis, or active gastrointestinal (GI) bleeding within 6 months prior to randomization.
    • Has uncontrolled hypertension.
    • Has had an allogenic tissue/solid organ transplant.
    • .Has either had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery.

    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
  • Evaluation Of Immunological Responses Against Gynecologic Solid Tumors.

    Obtain fresh tumor tissue from high grade serous ovarian cancer, endometrial cancer, and cervical cancer and whole blood samples to support the development of future cancer therapies.

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    • Protocol Number:
      102202

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

      • Contacts:

      • New Jersey Medical School Prinicipal Investigator: Mark Einstein M.D
  • Exercise and Diet Intervention opTimized for gynecologic cancer Survivors: Development, Feasibility, and Acceptability of the EDITS Study. - NCT05466916

    A. Objectives Aim 1: Develop the MHBC intervention with components optimized for gynecologic cancer survivors (GCS). 1a) To develop the intervention components for physical activity and healthy dietary practices, we will conduct one-on-one interviews with stakeholders including GCS (n about 30; until thematic saturation) and gynecologic oncology clinicians (n about10; until thematic saturation). Clinician is operationalized as any cancer care health professional with direct gynecologic patient contact. Using directed content analysis, we expect to identify reasons for low uptake in MHBC interventions and gain insight on preferences for intervention components and characteristics such as component delivery (simultaneous vs. sequential), frequency of contact, delivery modality (in-person vs. remote), and support materials (e.g., workbooks and logs). We will then map the identified factors and preferences onto theoretical tenets and taxonomy to develop intervention components. 1b) To refine intervention design and components we will elicit GCS stakeholder input using a cross-sectional study design with an online questionnaire. A questionnaire will be administered to the same 30 GCS from Study 1a to obtain feedback identify intervention preferences. Aim 2: Determine the feasibility of the MHBC intervention and acceptability of components optimized among GCS. We will evaluate feasibility and acceptability of the 12-week MHBC intervention with 16 GCS. To determine feasibility, we will identify the number of intervention participants who enroll, complete the study, complete follow-up measures at Week 13, and track attendance. Based on previous MHBC interventions with GCS1, we anticipate that 30% will enroll, 85% will complete the intervention, 75% will complete measures at Week 13, and > 70% of the sessions will be attended. To determine acceptability, we will measure satisfaction with intervention components at Week 13. We predict that 86% intervention group will report high satisfaction (cutoff score: > 5 out 7). Aim 3 (exploratory): Assess the preliminary effects of the intervention on behavioral and cardiometabolic outcomes. We will assess the preliminary effects of the intervention on behavioral outcomes including physical activity, healthy dietary practices, HRQOL and cardiometabolic outcomes including weight, waist circumference, body composition (% body fat), and blood pressure.

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    • Protocol Number:
      132205

    • Principal Investigator:
      Angela Fong

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Ovary,Other Female Genital

      • Contacts:

      • Rutgers University Prinicipal Investigator: Angela Fong

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      Only women will be eligible if they meet the following criteria: :
    • 18 years old
    • A confirmed diagnosis of gynecologic cancer, Stage > I
    • Have completed treatment within five years prior to study commencement and hormonal replacement therapy is acceptable
    • Are not active, defined as engaging in < 150 minutes of moderate-to-vigorous physical activity per week
    • Have a potential unhealthy diet, defined as consuming < 2.5 servings of fruits and vegetables per day, or fast foods more than once per week over the past month
    • Are able to converse in and understand English

    Exclusion Criteria:

      Women will be excluded if they meet any of the following criteria:
    • Respiratory, joint, or cardiovascular problems precluding physical activity as per physical activity safety screening questionnaire;
    • Metastatic disease
    • Planned elective surgery during the duration of the intervention and/or follow-up that would interfere with participation (e.g., reconstructive surgery).

    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
  • Trial of Maintenance with Niraparib in patients with stage III, stage IV or platinum-sensitive Recurrent Uterine Serous Carcinoma. - NCT04080284

    Primary Objective: To determine the Progression Free Survival (PFS) at 1 year in the proposed Niraparib regimen in the population of patients with stage III, all stage IV, or recurrent uterine serous carcinoma (USC). Secondary Objectives: 1. Progression-free survival (PFS), Overall Survival (OS), Overall response rate (ORR) at 2, and 3 years interval from start of treatment protocol. 2. To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in patients with stage III, all stage IV, or recurrent uterine serous carcinoma (USC). 3. To identify the prevalence of somatic mutations, HRD mutations, and overall mutational burden in patients with USC and classify tumor into loss of heterozygosity (LOH) high and low phenotype. 4. To evaluate quality of life (QOL) for the subjects undergoing this treatment, using validated tools. QOL will be assessed every 3 months during treatment course.

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    • Protocol Number:
      102101

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Other Female Genital

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Niraparib

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Female, age at least 18 years 2. ECOG performance status of <2 3. Written voluntary informed consent 4. Histologically diagnosed Uterine Serous Carcinoma. 5. Patient must agree to undergo Foundation One testing. 6. Patient diagnosed with advanced stage USC including stage III, stage IV, or platinum-sensitive recurrent USC 7. If recurrent USC, patient must have platinum sensitive disease after initial treatment; defined as achieving a response (CR or PR) and disease progression >6 months after completion of their last dose of platinum chemotherapy. 8. Patients eligible if receiving 1st or 2nd line chemotherapy for recurrence. 9. The patient must have achieved a partial, stable, or complete tumor response following the last chemotherapy (minimal of 3 cycles) regimen of physician choice chemotherapy indicating partial, stable, complete tumor response. 10. Patients must receive Niraparib maintenance within 12 weeks after completion of their final dose of chemotherapy regimen or within 14 weeks if received radiation therapy. CT Chest/Abd/Pelvis will be performed within 28 days of starting Niraparib. 11. Lesions can be non-measurable or measurable by RECIST 1.1 criteria. 12. Adequate organ function, defined as: 1. Absolute neutrophil count ≥ 1,500/μL 2. Platelets ≥ 100,000/μL 3. Hemoglobin ≥ 9 g/dL 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation 5. Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN 6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN 13. Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy. 14. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment. 15. Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non childbearing potential. Non childbearing potential is defined as follows (by other than medical reasons): 1. ≥45 years of age and has not had menses for >1 year Patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See Section 6.4 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient. 2. Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment. 3. Able to take oral medications.

    Exclusion Criteria:

    • 1. Participant must not be simultaneously enrolled in any interventional clinical trial 2. Drainage of ascites during the last 2 cycles of last chemotherapy 3. Radiotherapy was given within 2 weeks encompassing >20% of the bone marrow or any radiation therapy within one week prior to Day 1 of protocol therapy. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy. 4. Persistent >Grade 2 anemia, neutropenia, or thrombocytopenia from prior cancer therapy, that has persisted > 4 weeks and was related to the most recent treatment. 5. Symptomatic uncontrolled brain or leptomeningeal metastases. 6. Known hypersensitivity to the components of Niraparib 7. Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery 8. Diagnosis, detection, or treatment of invasive cancer other than uterine cancer

    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
  • Web-Based Coping and Communication Skills Intervention for Women who are newly diagnosed with Gynecological Cancer: A Pilot Study.

    1) To collect feedback from patients on CCI online and to assess patients evaluation to CCI online 2) To examine the feasibility and acceptability of a CCI online 3) To collect pilot data on the impact of CCI online on depression, anxiety, cancer-specific distress, fear of recurrence, and psychological well-being, as well as on coping efficacy and coping skills

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    • Protocol Number:
      131908

    • Principal Investigator:
      Sharon Manne PhD

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Ovary,Cervix

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Manne PhD
    • Rutgers Cancer Institute of New Jersey
  • ZN-C3-006: A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination with Niraparib in Subjects with Platinum-Resistant Ovarian Cancer. - NCT05198804

    Primary Objectives: Phase 1: To investigate the safety and tolerability of ZN-c3 in combination with niraparib, including identification of the MTD and RP2D. Phase 2: To investigate the antitumor activity of ZN-c3 in combination with niraparib. Secondary Objectives: - To further investigate the antitumor activity of ZN-c3 in combination with niraparib. - To investigate the OS of subjects receiving ZN-c3 in combination with niraparib. - To investigate the safety and tolerability of ZN-c3 in combination with niraparib. - To evaluate changes in PROs and quality of life. - To investigate the plasma PK of ZN-c3 and niraparib when given in combination.

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    • Protocol Number:
      102204

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Niraparib ZN-c3

      • Contacts:

      • New Jersey Medical School Prinicipal Investigator: Mark Einstein M.D

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria:

      1. Female and at least 18 years old. 2. Histologically or cytologically confirmed recurrent high grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with histologic subtypes of serous, clear cell or endometrial for which there is no known or established treatment available with curative intent. 3. Have demonstrated relapse within 6 months of platinum therapy (platinum-free interval <6 months). 4. Must have evaluable or measurable disease according to RECIST v1.1 criterion: defined as at least one lesion that can be accurately measured. 5. Adequate hematologic and organ function. 6. Ability and willingness to take oral medication. 7. If unknown homologous recombination deficiency (HRD) status, subjects must provide formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation. 8. Willingness to release archival tissue for research purposes or to undergo a tumor tissue biopsy prior to dosing on Cycle 1 Day 1.

      Additional Key Inclusion Criteria for Phase II:

        9. This supersedes inclusion criterion 3 (above). Demonstrated relapse within 6 months of platinum therapy, while taking a PARPi as maintenance: a minimum of 3 months is required if the participant received PARPi maintenance following first-line chemotherapy. 10. Must have measurable disease according to RECIST V1.1 criterion: defined as at least one lesion that can be accurately measured.

      Key Exclusion Criteria:

        1. Prior therapy directed at the malignant tumor within the last four weeks prior to Cycle 1 Day 1 (6 weeks for nitrosoureas or mitomycin C). 2. A minimum of 10 days between termination of the prior PARPi and administration of ZN-c3 and niraparib treatment is required. 3. Any investigational drug therapy <28 days. 4. Prior treatment with a WEE1 inhibitor. 5. Known hypersensitivity to any drugs similar to ZN-c3 and/or niraparib in class or its excipients. 6. Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 7. Uncontrolled hypertension (Diastolic BP > 90 mmHg or Systolic BP > 140 mmHg). 8. Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV). 9. Significant gastrointestinal abnormalities, requirement for IV alimentation, active peptic ulcer, chronic diarrhea, or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption. 10. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid. 11. History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP). 12. Taking medications with a known risk of TdP (according to current information provided at https://crediblemeds.org).

    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.