-
A Feasibility Study of E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-Associated Cancers.
- NCT05639972
Primary Objective:
- To determine the feasibility of administering E7 TCR-T cell therapy as induction treatment for LAHPVC
Secondary Objectives:
- To determine the objective tumor response rate at 6-weeks after treatment
- To assess 2-year and 5-year disease free survival (DFS)
- To collect biospecimens for exploratory translational research
View All Details
-
Protocol Number:
192104
-
Principal Investigator:
Christian Hinrichs
-
Phase:
Phase I
-
Scope:
Local
-
Applicable Disease Sites:
Breast
,Cervix
,Lip, Oral Cavity and Pharynx
,Other Female Genital
,Other Male Genital
,Stomach
-
Therapies Involved:
Immunotherapy
-
Drugs Involved:
TCR-T Cell infusion
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria: Subjects must meet all the following criteria to participate in this
study. 1. Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol. 2. Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. 3. HLA-A*02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A*02) but the HLA-A*02:01 allele type must be confirmed prior to apheresis. 4. Measurable disease per RECIST Criteria Version 1.1 or PERCIST. 5. Age ≥ 18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening. 7. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy. 8. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 9. Seronegative for HIV antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by reverse transcription polymerase chain reaction (RT-PCR) must be negative. 10. Participants must have organ and marrow function as defined below: 1. Leukocytes > 3,000/mcL 2. Absolute neutrophil count > 1,500/mcL 3. Platelets > 100,000/mcL 4. Hemoglobin > 9.0 g/dL 5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. 6. Serum aspartate aminotransferase (AST) (SGOT)/ alanine transaminase (ALT) (SGPT) < 2.5 x upper limit of normal (ULN) 7. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation). 8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage. 11. Participants must be able to understand and be willing to sign the written informed consent document. 12. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) for biospecimen studies.Note: Patients may have undergone minor surgical procedures with the past three weeks, aslong as all toxicities have recovered to Grade 1 or less.
Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from
participation in this study: 1. Have received prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. Palliative radiation therapy for symptom management, such as to control tumor-induced bleeding, is permitted. 2. Current treatment with another investigational agent. 3. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study. 4. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements. 5. Subjects with HLA-A*02:01 damaging mutation or allele loss detected by research or clinical sequencing will not be eligible. 6. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations: 1. Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or 2. Age ≥ 50 years old 7. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, they may be reevaluated. 8. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study. 9. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment. 10. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications). 11. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible. 12. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to: 1. Carcinoma in situ 2. Cutaneous skin cancers requiring only local excision 3. Low grade non-muscle invasive bladder cancer 4. Low grade prostate cancer 13. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible. 14. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.
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.
-
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.
- 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
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Individuals 35-50 years of age, inclusive
- Patients who will undergo risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted
- At least one intact ovary and fallopian tube is in situ at the time of counseling, consent, and registration. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present
- Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required
- Patients may be premenopausal or menopausal
- Pelvic ultrasound (transvaginal imaging preferred, but transabdominal imaging is acceptable) or pelvic MRI 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
- Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future
Exclusion Criteria:
- Individuals with a history of any prior cancer who have received cytotoxic chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time. Endocrine therapy or maintenance ERBB2/HER2 targeted therapy is allowed. Maintenance immune checkpoint inhibitor therapy is allowed. Maintenance therapy with PARP in inhibitor is allowed.
- 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 (pelvic ultrasound, pelvic MRI, CA-125) suspicious for occult or gross pelvic malignancy within the past 180 days
- An abnormal pelvic ultrasound (or pelvic MRI) is defined as morphologic or structural variations suspicious for ovarian malignancy. Complex cystic lesions felt to represent a benign lesion are not exclusionary. Simple cysts of any size are not exclusionary
- An abnormal CA-125 is defined as a level > 50U/ml in premenopausal individuals if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40U/ml for premenopausal individuals who are current users of oral contraceptives (Skates 2011). An abnormal CA-125 is defined as a level > 35 U/ml in postmenopausal individuals
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.
-
A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination with Gemcitabine in Adult Subjects with Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature® Status.
- NCT05548296
Primary Objective:
Phase 2 Simon 2-Stage Study (Arm 1 Monotherapy):
- Assess the anti-tumor activity of ACR-368 monotherapy in each cohort (ovarian, endometrial, urothelial) of OncoSignature Positive subjects.
Phase 1b (Arm 2 Combination Therapy):
- Assess the safety and tolerability of ACR-368 in combination with LDG.
- Determine the RP2D of LDG.
Phase 2 Exploratory Study (Arm 2 Combination Therapy):
- Assess the anti-tumor activity of ACR-368 in combination with LDG in each cohort (ovarian, endometrial, urothelial) of OncoSignature Negative subjects.
View All Details
-
Protocol Number:
102302
-
Principal Investigator:
Aliza Leiser
-
Phase:
Phase I/II
-
Scope:
National
-
Applicable Disease Sites:
Other Female Genital
-
Therapies Involved:
Chemotherapy multiple agents systemic
Chemotherapy single agent systemic
-
Drugs Involved:
ACR-368
LDG
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria: General
1. Participant must be able to give signed, written informed consent. 2. Participant must have histologically documented, high-grade endometrial cancer. Arms 1 and 2 1. All high-grade epithelial endometrial histological subtypes are eligible including: endometrioid (all Grade 3), serous, carcinosarcomas, clear-cell carcinoma, and mixed histologies. Note: Subjects with p53 mutant Grade 2 endometrioid cancer are eligible Arms 3 and 4 2. Serous carcinoma or mixed tumors with a majority component of serous carcinoma or carcinosarcoma where the carcinomatous component is serous carcinoma. 3. Treatment History Requirements: Arms 1 and 2 1. Subject must have received prior platinum-based chemotherapy 2. Subject must have received prior anti-PD-(L)1 therapy 3. Subject must not have received more than three lines of prior systemic therapy Arms 3 and 4 1. Subject must have received prior platinum-based chemotherapy 2. Subject must have received prior anti-PD-(L)1 therapy 3. Subject must not have received more than two lines of prior systemic therapy 4. Participant must have histologically confirmed metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen. 5. Participant must have at least 1 measurable lesion per RECIST v1.1 criteria (by local Investigator) in a baseline tumor imaging that has been obtained within 28 days of the treatment start. Participant must have radiographic evidence of disease progression based on RECIST v1.1 criteria following the most recent line of treatment. 6. Arm 1 and 2 only: Participant must be willing to provide tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated after written informed consent. Newly obtained is defined as a specimen taken after written informed consent is obtained, during the 28-day Screening period. Note: Subjects at EU sites are not eligible for Arm 1 and Arm 2 7. For all subjects participating in Arm 3 and 4, archival tumor tissue must be provided either during or after screening either as a tissue block or at least 20 unstained slides. 8. Participant must have stabilized or recovered (Grade 1 or baseline) from all prior therapy related toxicities, except as follows: 1. Alopecia is accepted. 2. Endocrine events from prior immunotherapy stabilized at ≤ Grade 2 due to need for replacement therapy are accepted (including hypothyroidism, diabetes mellitus, or adrenal insufficiency). 3. Neuropathy events from prior cytotoxic therapies stabilized at ≤ Grade 2 are accepted. 9. Participant must have an Eastern Cooperative Oncology Group Performance Status 0 or 1. 10. Participant must have an estimated life expectancy of longer than 3 months in the clinical judgment of the investigator. 11. Participant must have adequate organ function at Screening, defined as: 1. Absolute neutrophil count > 1500 cells/µL without growth factor support within 2 weeks prior to obtaining the hematology values at Screening. 2. Hemoglobin ≥ 9.0 g/dL. 3. Platelets ≥ 150,000 cells/µL without transfusion within 1 week prior to obtaining the hematology values at Screening. 4. Renal function is defined as Glomerular filtration rate (GFR) ≥ 50 mL/min/1.73m2. Note: GFR may be estimated using site standard methods (e.g., CKD-EPI, MDRD, or Cockcroft-Gault) or measured using 24-hour urine collection or Chrome-EDTA clearance, as per site standard practice. 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); ≤ 5 × ULN if liver metastases are present. 6. Total bilirubin ≤ 1.5 × ULN not associated with Gilbert's syndrome. If associated with Gilbert's syndrome ≤ 3 x ULN is acceptable. 7. Serum albumin ≥ 3 g/dL. 12. Participant must have adequate coagulation profile as defined below if not on anticoagulation. If subject is receiving anticoagulation therapy, then subject must be on a stable dose of anticoagulation for ≥ 1 month: 1. Prothrombin time within 1.5 x ULN. 2. Activated partial thromboplastin time within 1.5 x ULN.
Exclusion Criteria: General
1. Participant with known symptomatic brain metastases requiring > 10 mg/day of prednisolone (or its equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of ACR-368 treatment, fulfill the steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥ 4 weeks after treatment. 2. Participant has mesenchymal tumors of the uterus. 3. Participant has a history of clinically meaningful ascites, defined as history of paracentesis or thoracentesis with therapeutic intent, within 4 weeks of Screening. Subjects with planned therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1 dosing are excluded. 4. Participant had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug. 5. Participants has known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is considered uncontrolled based on the criteria included in Appendix 2. 6. Participant has a history of clinically meaningful coagulopathy, bleeding diathesis. 7. Participant has cardiovascular disease, defined as: 1. Uncontrolled hypertension defined as blood pressure > 160/90 mmHg at Screening confirmed by repeat (medication permitted). 2. History of torsades de pointes, significant Screening electrocardiogram (ECG) abnormalities, including ventricular rhythm disturbances, unstable cardiac arrhythmia requiring medication, pathologic symptomatic bradycardia, left bundle branch block, second degree atrioventricular (AV) block type II, third degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia not amenable to correction, congenital long QT syndrome, prolonged QT interval due to medications, corrected QT based on Fridericia's formula (QTcF) > 450 msec (for men) or > 470 msec (for women). 3. Symptomatic heart failure (per New York Heart Association guidelines; (Caraballo, 2019), unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction < 20%, transient ischemic attack, or cerebrovascular accident within 6 months of Day 1). 8. Participant has a history of major surgery within 4 weeks of Screening. 9. Participant has experienced bowel obstruction related to the current cancer within the last 4 weeks or signs or symptoms of intestinal obstruction, which include nausea, vomiting, or objective radiologic finding of bowel obstruction in the last 4 weeks before the start of the treatment. 10. Participant has taken a prior cell cycle CHK1 inhibitor, including ACR-368
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.
-
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.
View All Details
-
Protocol Number:
111702
-
Principal Investigator:
Nehal Parikh
-
Phase:
Phase III
-
Scope:
National
-
Applicable Disease Sites:
Any Site
,Ovary
,Prostate
-
Therapies Involved:
Chemotherapy multiple agents systemic
-
Drugs Involved:
BLEOMYCIN
CARBOPLATIN
CISPLATIN
ETOPOSIDE
-
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: Patients 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 malignant 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 , with the following exceptions:
- Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart. The pathology report of initial surgery should be provided
- Patients may be enrolled without histologic or cytologic confirmation in the rare case where there are exceptionally raised tumor markers (alpha fetoprotein [AFP- ≥ 500 ng/mL or HCG ≥ 500 IU/L) and radiologic features consistent with GCT. In addition, the treating clinician must deem that the patient's tumor is not suitable for upfront resection and that a biopsy is not in the patient's best interest; or that there is a need to start therapy urgently
- Low risk immature teratoma (IT); site: ovarian; stage: any; grade: any; histology: pure immature teratoma, mixed immature and mature teratoma, (may contain microscopic foci of yolk sac tumor [< 3 mm], but no other 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 only seminoma; 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-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, III, and III-X, 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: 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
- Notes:
- IGCCC criteria only apply to SR2 patients with a testicular primary tumor
- Use post-op tumor marker levels to determine IGCCC risk group
- Pure 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/sex 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 =< 2 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
- Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN) (within 7 days prior to enrollment)
- Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome
- Peripheral absolute neutrophil count (ANC) >= 750/mm^3 (within 7 days prior to enrollment) AND
- Platelet count >= 75,000/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 ovarian or extragonadal dysgerminoma/seminoma
- Pure mature teratoma
- Pure immature teratoma with alpha-fetoprotein (AFP) >= 1000 ng/mL
- "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, 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.
-
A Phase II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers.
- NCT05686226
The primary objective of this trial is to determine the objective tumor response rate (CR+PR) and duration of response for treatment of recurrent/refractory or metastatic HPV-associated cancers with E7 TCR-T cells.
View All Details
-
Protocol Number:
192204
-
Principal Investigator:
Christian Hinrichs
-
Phase:
Phase II
-
Scope:
Local
-
Applicable Disease Sites:
Anus
,Cervix
,Larynx
,Lip, Oral Cavity and Pharynx
,Other Female Genital
,Other Male Genital
-
Therapies Involved:
Immunotherapy
-
Drugs Involved:
E7 TCR T cell
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria: Subjects must meet all the following criteria to participate in this
study. 1. Histologically or cytologically confirmed metastatic or refractory/recurrent HPV-16+ cancer. 2. Tumor and/or blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. 3. HLA-A*02:01 allele as determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A*02) but the HLA-A*02:01 allele type must be confirmed prior to apheresis. 4. Measurable disease as assessed by RECIST Criteria Version 1.1. 5. Age ≥ 18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening. 7. Must have received prior first line standard therapy or have declined standard therapy. 8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII). 9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery. 10. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy. 11. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 12. Seronegative for HIV antibody, hepatitis B antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for hepatitis C (HCV) RNA must be negative. 13. Participants must have organ and marrow function as defined below: 1. Leukocytes > 3,000/mcL 2. Absolute neutrophil count > 1,500/mcL 3. Platelets > 100,000/mcL 4. Hemoglobin > 9.0 g/dL 5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. 6. Serum aspartate transferase (AST) (SGOT)/alanine transaminase (ALT) (SGPT) < 2.5 x upper limit of normal (ULN) 7. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation). 8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage. 14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability for the protocol. 15. Participants must be able to understand and be willing to sign the written informed consent document. 16. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.Note: Participants may have undergone minor surgical procedures with the past threeweeks, as long as all toxicities have recovered to Grade 1 or less.
Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from
participation in this study: 1. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements. 2. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study. 3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test. 4. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations: 1. Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or 2. Age ≥ 50 years old 5. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated. 6. Subjects with HLA-A*02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible. 7. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study. 8. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment. 9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications). 10. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible. 11. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to: 1. Carcinoma in situ 2. Cutaneous skin cancers requiring only local excision 3. Low grade non-muscle invasive bladder cancer 4. Low grade prostate cancer Participants with prior or concurrent malignancy that do not meet the above criteria are excluded. 12. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible. 13. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data. 14. Current treatment with another investigational agent. 15. Hepatic metastases unless ≤ 5 lesions and no lesion ≥ 5 cm in greatest dimension. 16. Prior catheter related locoregional therapies to the liver: embolization (TAE), transarterial chemoembolization (TACE), transarterial radioembolization (TARE).
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.
-
A Phase III Trial of One vs. Two Years of Maintenance Olaparib, with or Without Bevacizumab, in Patients with BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy.
- NCT06580314
Primary Objective:
To determine investigator assessed progression-free survival using RECIST v1.1 (non-inferiority) for one vs. two years of maintenance olaparib. This analysis is supported by a modified ITT population limited to patients on protocol at least 360 days after randomization. The time at risk for this population starts 360 days after randomization (Section 15.3). This analysis is denoted PFS360.
Secondary Objectives:
1. To evaluate overall survival (OS360) in the modified ITT population, with time at risk for progression/death starting 360 days after randomization.
2. To evaluate PFS, PFS2 and OS in the ITT population.
3. To evaluate PFS, PFS2, and OS in the as-treated population.
4. To evaluate toxicity, including rates of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and other secondary malignancies, in the safety population.
View All Details
-
Protocol Number:
102504
-
Principal Investigator:
Aliza Leiser
-
Phase:
Phase III
-
Scope:
National
-
Applicable Disease Sites:
Ovary
-
Therapies Involved:
Chemotherapy multiple agents systemic
-
Drugs Involved:
BEVACIZUMAB
Olaparib
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types:
- High grade serous
- High grade endometrioid (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated)
- Carcinosarcoma (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated), and/or
- Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic), (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated)
- Submission of pathology report is required
- Ovarian cancer = ovarian, fallopian, or primary peritoneal cancer
- Patients must have:
- Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration)
- Submission of testing report is required. OR
- BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory (e.g., Myriad MyChoice©)
- Submission of testing report is required
- Patient must have undergone cytoreductive surgery (primary or interval)
- Patients must have completed first line platinum-based therapy prior to registration:
- Platinum based chemotherapy course must have consisted of a minimum of 4 treatment cycles and a maximum of 9, although it is strongly recommended that patients receive at least 6 cycles unless medically contraindicated
- For those receiving less than 6 cycles of platinum-based therapy, the reason for this must be documented and could include hematologic toxicity or non-hematologic toxicities directly related to therapy
- Intravenous, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle
- Patients must not have received an investigational agent during their first line course of chemotherapy
- Patients must have, in the opinion of the investigator, no clinical evidence of disease progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy)
- Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression and patients are neurologically stable off steroid therapy
- Patients must be randomized at least 3 weeks and no more than 12 weeks after their last dose of chemotherapy (last dose is the day of the last infusion of platinum agent)
- No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Not pregnant and not nursing
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3
- Platelets ≥ 100,000 cells/mm^3
- Hemoglobin ≥ 9 g/dl
- Creatinine clearance (CrCL) of > 30 mL/min by the Cockcroft-Gault formula
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- No active infection requiring parental antibiotic(s)
- No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
- No current inability to swallow orally administered medication
- No history of myelodysplastic syndrome and/or acute myeloid leukemia
- No history of allogeneic bone marrow transplant
- No concomitant use of strong or moderate CYP3A inducers
- No known hypersensitivity to olaparib or any of the excipients of the product
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.
-
A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumors.
- NCT02582697
Primary Objectives:
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).
View All Details
-
Protocol Number:
111904
-
Principal Investigator:
Nehal Parikh
-
Phase:
Phase III
-
Scope:
National
-
Applicable Disease Sites:
Other Female Genital
,Other Male Genital
-
Therapies Involved:
Chemotherapy multiple agents systemic
-
Drugs Involved:
CISPLATIN
ETOPOSIDE
IFOSFAMIDE
MESNA
Pegfilgrastim
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
1. Age ≥ 11 years and ≤ 50 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 hasb. non-seminoma by IGCCC criteria or stage IV malignant ovarian germ cell tumour 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). Acceptable regimens include cisplatin 20 mg/m2 days 1-2 and etoposide 100 mg/m2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m2 days 1-2; or baby-BOP.43 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 abuseThe 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 thestudy with the exception of the Children's Oncology Group who will be participate instage 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.
-
A Randomized Phase III Trial of Carboplatin, Paclitaxel, Pembrolizumab versus Carboplatin, Paclitaxel, Bevacizumab versus Carboplatin, Paclitaxel, Pembrolizumab, Bevacizumab In The Treatment of pMMR, TP53 Mutated Advanced or Recurrent Endometrial Cancer.
- NCT07198074
Primary Objective:
To demonstrate that bevacizumab, an anti-VEGF antibody therapy, (or an anti-VEGF antibody biosimilar) in combination with carboplatin, paclitaxel, and pembrolizumab is superior to carboplatin, paclitaxel, and pembrolizumab (the control arm) or carboplatin, paclitaxel, and bevacizumab in prolonging PFS in patients with pMMR, TP53 mutated advanced stage (III or IV) or recurrent endometrial cancer.
Secondary Objectives:
- To demonstrate that bevacizumab in combination with carboplatin, paclitaxel, and pembrolizumab is superior to carboplatin, paclitaxel, and pembrolizumab or carboplatin, paclitaxel, and bevacizumab in prolonging OS in patients with pMMR, TP53 mutated advanced stage (III or IV) or recurrent endometrial cancer.
- To examine the impact of the addition of bevacizumab in combination with carboplatin and paclitaxel or with carboplatin, paclitaxel, and pembrolizumab on PFS and OS based on type of p53 IHC aberrancy (over expression/cytoplasmic expression versus null [complete absence of staining]) and mutation type.
- To evaluate toxicity on treatment with bevacizumab when combined with carboplatin, paclitaxel, and/or pembrolizumab as assessed by CTCAE v.5.0.
- To explore the anti-tumor activity in each treatment arm as assessed by objective response rate in the subset of patients with measurable disease by RECIST 1.1.
View All Details
-
Protocol Number:
102601
-
Principal Investigator:
Eugenia Girda
-
Phase:
Phase III
-
Scope:
National
-
Applicable Disease Sites:
Other Female Genital
-
Therapies Involved:
Chemotherapy multiple agents systemic
-
Drugs Involved:
BEVACIZUMAB
CARBOPLATIN
PACLITAXEL
Pembrolizumab (MK-3475)
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Documentation of disease:
- Stage III and stage IVA endometrial cancers (with measurable disease),
- Stage IVB endometrial cancer (with or without measurable disease), or
- Recurrent endometrial cancer (with or without measurable disease)
- In patients with measurable disease, lesions will be defined and monitored by RECIST 1.1. Measurable disease (RECIST 1.1) is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT or MRI. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI
- Histologic confirmation of the original primary tumor is required (submission of pathology report[s] is required). Patients with the following histologic types are eligible: endometrioid, serous, dedifferentiated/undifferentiated, clear cell, mixed epithelial, carcinosarcoma, adenocarcinoma not otherwise specified (N.O.S.)
- Patients must have:
- Tumoral mismatch repair proficient (pMMR) disease as assessed by immunohistochemistry (IHC) AND
- P53 IHC with aberrant staining pattern (aberrant p53 expression is consistent with mutant TP53). TP53 mutation by next-generation sequencing will also be accepted
- A pathology report demonstrating results of institutional MMR IHC and p53 IHC and/or TP53 by next-generation sequencing
- Patients may have received:
- NO prior chemotherapy for treatment of endometrial cancer OR
- Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy [with or without cisplatin]) provided adjuvant chemotherapy was completed ≥ 12 months prior to registration
- Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration. For patients with recent radiation, they must have RECIST-evaluable disease outside of the radiation field and have recovered their marrow function
- Patients may have received prior hormonal (endocrine) therapy. All hormonal (endocrine) therapy must have been completed at least 1 week prior to registration
- NO prior pembrolizumab (or other anti-PD1, anti-PDL1 or anti-CTLA4 therapy) or bevacizumab (or other antiangiogenic therapy)
- Interval or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of disease progression. Patients with brain metastases must have follow up imaging demonstrating no evidence of disease progression and that the disease is stable off of steroids
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Not pregnant and not nursing
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3
- Platelets ≥ 100,000 cells/mm^3
- Hemoglobin ≥ 8 g/dl
- Creatinine clearance (CrCl) of ≥ 30 mL/min by the Cockcroft-Gault formula
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
- No active infection requiring parenteral antibiotics
- No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
- No clinically significant bleeding within 28 days prior to registration
- No uncontrolled hypertension, defined as systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg
- No major surgery within 28 days of initiation of bevacizumab
- No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease
- Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible
- Topical or inhaled steroids are allowed
- Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), and anti-thyroid antibodies should be evaluated with the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
- No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
- No history of stem cell or solid organ transplant
- No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)
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.
-
Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer: A Phase I/II Feasibility Study.
- NCT07643012
Primary Objective:
1. To assess acute toxicity of moderately hypofractionated MR-guided adaptive pelvic IMRT using the Common Terminology Criteria for Adverse Events (CTCAE v6.0).
Secondary Objectives:
1. To report patient-reported outcomes using EORTC (European Organisation for Research and Treatment of Cancer) core questionnaire (QLQ-C30) with EN24 companion
2. To assess late toxicity of moderately hypofractionated MR-guided adaptive pelvic IMRT using the Common Terminology Criteria for Adverse Events (CTCAE v6.0).
3. To assess locoregional recurrence and disease-free survival.
4. To assess the feasibility and dosimetric advantages
View All Details
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
1. Histologically confirmed endometrial carcinoma (endometrioid, serous, clear cell, carcinosarcoma, or dedifferentiated histology). 2. Indication for adjuvant pelvic radiotherapy (± vaginal brachytherapy) for HIR defined by the ASTRO guidelines and GOG-99(7, 9) : 3. Age 4. High-grade histology (grade 2-3) 5. Depth of myometrial invasion 6. LVSI 7. Positive pelvic nodes 8. Cervical stromal invasion 9. Presence of poor prognostic molecular markers 10. Age ≥18 years. 11. Ability to provide informed consent. 12. Eligible to receive adjuvant systemic therapy, if indicated, with a minimum 3-week interval between chemotherapy and radiotherapy. 13. Willing and able to complete EORTC QLQ-C30 and EN-24 questionnaires in a validated language version.
Exclusion Criteria:
1. Prior pelvic radiotherapy. 2. Contraindication to pelvic radiotherapy (e.g., active connective tissue disorder or inflammatory bowel disease). 3. Presence of a hip prosthesis that would compromise treatment planning or delivery.
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.
-
Personalized Oncology Promoting Equity for Black Lives (PROPEL).
- NCT06073626
The specific aims of this study are: 1) Test the efficacy of a culturally tailored and interactive electronic relational agent (RA) intervention vs. enhanced usual care (EUC) consisting of clinical letter and genetic recommendation on engagement in genetic education and genetic testing uptake; 2) Evaluate the impact of the RA vs. EUC on informed decision-making and psychosocial outcomes; and 3) Explore potential mechanisms by assessing mediators and moderations of efficacy.
View All Details
-
Protocol Number:
132309
-
Principal Investigator:
Anita Y Kinney
-
Phase:
N/A
-
Scope:
National
-
Applicable Disease Sites:
Breast
,Colon
,Corpus Uteri
,Ovary
,Pancreas
,Prostate
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- 18-80 years of age
- Self-identify as Black or African American
- At least 6-months post diagnosis with any of the following cancers: breast, ovarian, uterine, prostate, colorectal, pancreatic
- Have not had genetic testing for hereditary cancer
- Have received care at one of the participating sites in the prior five years
- Meet National Comprehensive Cancer Network criteria for germline GT
- Able to read and speak in English
- Capable of providing informed consent
- Have internet access (via smartphone, tablet or computer)
- Comfortable using a computer or mobile phone independently to access information
Exclusion Criteria:
- Do not speak English
- Unable to access the Internet
- Have previously undergone germline genetic testing for hereditary cancer risk or previously had genetic counseling (GC) and declined genetic testing (GT)
- Are unable to provide 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.
-
TREAT-EC (Tirzepatide in the Treatment of Endometrial Cancer) A Phase II Pilot Clinical Trial).
- NCT07605247
Primary Objective :
To determine the effect of levonorgestrel intrauterine system (LNG-IUD), with sequential addition of tirzepatide, on the pathological complete response (pCR) rate at 9 months (36 weeks) in patients with early-stage, FIGO grade 1 or 2, p53 WT, MMR proficient EC or EIN and a BMI > 27 kg/m2.
View All Details
-
Protocol Number:
102506
-
Principal Investigator:
Eugenia Girda
-
Phase:
Phase II
-
Scope:
National
-
Applicable Disease Sites:
Corpus Uteri
-
Therapies Involved:
Chemotherapy single agent systemic
-
Drugs Involved:
Tirzepatide
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
1. Histologically confirmed endometrial intraepithelial neoplasia (EIN), FIGO grade 1 or 2 endometrioid adenocarcinoma on a curette or endometrial biopsy. *EIN patients capped at a maximum of 50% of total enrollment ((≤10 patients). . 2. P53 wild-type and MMR proficient (or microsatellite stable) confirmed by immunohistochemistry. 3. Females with a BMI > 27 kg/m2 are at high risk of surgical complications due to comorbidities (diabetes, hypertension, cardiovascular disease, obstructive sleep apnea) or BMI > 30 kg/m2 with no comorbidities and have decided not to opt for immediate surgical intervention (having been advised that this is the standard of care); 4. Over 18 years of age at time of randomization; 5. CT scan of pelvis, abdomen, and chest (or chest X-Ray), suggesting the absence of extrauterine disease in patients with endometrial cancer only; 6. Myometrial invasion on MRI of not more than 50%; 7. No lymph vascular invasion on biopsy; 8. Serum CA125 ≤35 U/mL; 9. No known hypersensitivity or contraindications for LNG-IUD (severe liver disease, personal history of breast cancer, active pelvic inflammatory disease, congenital uterine abnormality) or GLP-1 agonist; 10. Ability to comply with endometrial biopsies at specified 3-monthly intervals; 11. Negative serum or urine pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause; 12. No LNG-IUD or LNG-IUD inserted < 6 weeks prior to enrollment; 13. Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
Exclusion Criteria:
1. ECOG performance status ≥3 (Appendix II); 2. Grade 1 or 2 endometrioid adenocarcinomaof the endometrium with myometrial invasion deeper than 50% on MRI, or any patients withgrade 3 endometrioid adenocarcinoma; 3. MMR deficient or p53 mutated endometrial cancer;4. Histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high-riskendometrial e.g., papillary serous, clear cell); 5. Pregnant or planning to becomepregnant during trial period; 6. Prior treatment for EAC; 7. Patients with a history ofpelvic or abdominal radiotherapy; 8. Unwilling to have additional endometrial biopsies orunable to attend monthly clinical assessments; 9. Unable to provide informed consent orcomplete questionnaires; 10. Evidence of extra-uterine extension on cross-sectionalimaging; 11. Congenital or acquired uterine anomaly that distorts the uterine cavity; 12.Acute pelvic inflammatory disease; 13. Genital actinomycosis; 14. History ofpancreatitis; 15. Diagnosis of Type 1 diabetes; 16. Previous treatment with GLP-1receptor agonists within the last 3 months; 17. Visit 1 thyroid-stimulatory hormoneoutside of the range of 0.4-6.0 mL/uL; 18. Obesity induced by other endocrine disorders(e.g., Cushing syndrome); 19. Current or history of treatment with medications that maycause significant weight gain within 3 months prior to screening visit, includingsystemic corticosteroids (except for a short course of treatment, i.e., 7-10 days orphysiologic replacement doses ≤10 mg/day prednisone equivalent), tri-cyclicantidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine,amitriptyline, mirtazapine, phenelzine, chlorpromazine, thioridazine, clozapine,olanzapine, valproic acid and its derivatives, and lithium); 20. Participation in aclinical trial of weight control within the last 3 months before screening for thistrial; 21. Previous surgical treatment for obesity (excluding liposuction if performed >1year before study entry); 22. History of major depressive disorder or a PHQ-9 >15 withinthe last 2 years (completed at visit 1) or history of other severe psychiatric disorders(e.g., schizophrenia or bipolar disorder) or diagnosis of an eating disorder such asrestrained eating, binge eating, or bulimia (based on Questionnaire for Diagnosing BingeEating Disorder and Bulimia Nervosa completed at visit 1); 23. Participants with alifetime history of a suicide attempt or history of any suicidal behavior within the pastmonth before entry into the trial; 24. Surgery scheduled for the trial duration period,except for minor surgical procedures, at the discretion of the Investigator; 25. Impairedliver function, defined as screening aspartate aminotransferase or alanineaminotransferase ≥ 2.5 times the upper normal range (one re-test analyzed at the locallaboratory within 1 week prior to screening is permitted, with the last sample beingconclusive); 26. Impaired renal function is defined as serum creatinine ≥ 1.72 mg/dl (1retest within 1 week prior to screening through the local laboratory is permitted, withthe result of the last sample conclusive); 27. Known clinically significant activecardiovascular disease, including history of unstable angina, acute coronary event, othersignificant cardiac events (including history of arrhythmias, myocardial infarction (MI),or conduction delays on electrocardiogram [ECG]), or cerebral stroke within the past 6months and/or heart failure (New York Heart Association [NYHA] Class III or IV) at thediscretion of the Investigator; 28. Uncontrolled treated/untreated hypertension (systolicblood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg). If white-coathypertension is suspected at the screening visit, a repeated measurement at run-in beforeother trial-related activities is allowed; 29. Known history of substance abuse; 30.Language barrier, mental incapacity, unwillingness, or inability to understand andcomplete the mental health questionnaire in the provided language; 31. History of breast,thyroid or colon cancer. Patients with any prior diagnosis of thyroid cancer are noteligible for this study 32. Current other cancer. Patients with any current malignancy orpast malignancy in the past 5 years are not eligible. Excluded are treated basal cellcarcinoma or squamous cell carcinoma. (past or present, except basal cell skin cancer orsquamous cell skin cancer). Patient who have received any active treatment for anothermalignancy within 2 years prior to enrollment are not eligible); 33. Breastfeedingmothers
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.
-
Video Education with Result Dependent dIsclosure (VERDI)
- NCT05225428
The overall study objective is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.
This developmental work is imperative as the VERDI models utilized at DFCI in research studies #18-411 (ProActive), #17-409 (ProGen), #19-068 (OPT-IN), and #19-652 (GeneBOPP) have been overwhelmingly used in DFCI patients of Caucasian ancestry. While DFCI participants have responded well, in an effort improve the generalizability of VERDI and expand it to a diverse patient population, qualitative feedback is being sought explicitly from patients who self-identify as Black and Latinx patients.
A brief qualitative assessment among a small, cohort of English and Spanish speaking Black and Latinx participants will first be conducted to identify refinements to video education (VE) that may increase the utility of the VERDI model for patients in these traditionally underserved populations. Participants in the qualitative assessment study will receive VE exclusively for pretest education, followed by a short interview with research staff regarding their experiences with the VE model. The qualitative assessment study will precede a large-scale randomized controlled trial of VERDI vs standard genetic counseling (SGC), as informed by the results of the developmental study.
We hypothesize that the data yielded from the completion of the study objectives will assist in further refining the VERDI model and its use in clinical practices for the purpose of increasing genetic testing uptake and improving patient outcomes in minority populations that have been underrepresented in similar research to date.
View All Details
-
Protocol Number:
042207
-
Principal Investigator:
Deborah L Toppmeyer
-
Phase:
N/A
-
Scope:
National
-
Applicable Disease Sites:
Breast
,Colon
,Kidney
,Melanoma, Skin
,Ovary
,Pancreas
,Prostate
,Soft Tissue
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma
- Ability to understand spoken or written English or Spanish in a healthcare context
- Ability to understand and the willingness to sign a written informed consent document
- Black or Latinx (qualitative assessment study only)
Exclusion Criteria:
- Prior cancer genetic testing
- Prior germline genetic testing
- Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
- Currently pregnant
- Currently incarcerated
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.