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Clinical Trial

AHEP1531 Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT); A Phase 2/3 StudyCTMS#: 18-0100

This partially randomized phase II/III trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy after surgery may kill more tumor cells.

Clinical Trial

Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

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. Low risk patients are defined as Stage I patients, ages 0 50 years old. Since the trial is enrolling patients from pediatric oncology, gynecologic oncology and genito-urinary oncology (testicular cancer) the relevant staging criteria can be found in Appendices II (COG), III (FIGO), IV (AJCC) and V (IGCCC [International Germ Cell Consensus Classification]). The low risk arm will have two strata. One strata will include patients with an ovarian pure immature teratoma: COG Stage I (FIGO Stage IA and IB), Grade 2 or 3 with a maximum alpha fetoprotein ( -FP) of 1,000 ng/mL. The other low risk strata will be comprised of patients with COG Stage I (FIGO Stage IA and B; AJCC Stage IA and B) germ cell tumors at any extracranial site (testes, ovary, extragonadal) that have at least one malignant histology, defined as embryonal carcinoma, choriocarcinoma or yolk sac tumor. Patients with pure seminoma or dysgerminoma are excluded from this trial. Low risk patients who recur may receive treatment, if eligible, on the appropriate standard risk arm. Among standard risk patients the trial will evaluate whether cisplatin, which is the standard-of-care in COG, can be replaced with a less toxic alternative platin analogue, carboplatin. The standard risk arm will be divided into 2 age-based strata: (1) Standard Risk 1 (SR1) arm, which includes patients up to 11 years of age with COG Stage II - IV ovarian, testicular or extragonadal GCT and (2) Standard Risk 2 (SR2) arm, which includes patients between 11 and 25 years of age with COG Stage II III (FIGO Stage IC, II and III) ovarian, COG Stage II extragonadal and testicular, COG Stage II IV with IGCCC good risk disease. SR1 patients will be randomized to receive either 4 cycles of PEb (cisplatin, etoposide and bleomycin) or 4 cycles of CEb (carboplatin, etoposide and bleomycin). SR2 patients will be randomized to receive either 3 cycles of BEP (cisplatin, etoposide and bleomycin) or 3 cycles of BEC (carboplatin, etoposide and bleomycin). Bleomycin will be administered once per cycle for a total of 4 doses in SR1 patients versus weekly for a total of 9 doses in SR2 patients. Several corollary studies, including evaluation of toxicities (including patient-reported outcomes), pharmacogenetic analysis of adverse events, evaluation of a new miRNA diagnostic and prognostic test and molecular pathway analysis of pediatric, adolescent and young adult GCT are important components of this clinical trial.

Clinical Trial

AGCT1531, 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

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. Low risk patients are defined as Stage I patients, ages 0 50 years old. Since the trial is enrolling patients from pediatric oncology, gynecologic oncology and genito-urinary oncology (testicular cancer) the relevant staging criteria can be found in Appendices II (COG), III (FIGO), IV (AJCC) and V (IGCCC [International Germ Cell Consensus Classification]). The low risk arm will have two strata. One strata will include patients with an ovarian pure immature teratoma: COG Stage I (FIGO Stage IA and IB), Grade 2 or 3 with a maximum alpha fetoprotein ( -FP) of 1,000 ng/mL. The other low risk strata will be comprised of patients with COG Stage I (FIGO Stage IA and B; AJCC Stage IA and B) germ cell tumors at any extracranial site (testes, ovary, extragonadal) that have at least one malignant histology, defined as embryonal carcinoma, choriocarcinoma or yolk sac tumor. Patients with pure seminoma or dysgerminoma are excluded from this trial. Low risk patients who recur may receive treatment, if eligible, on the appropriate standard risk arm. Among standard risk patients the trial will evaluate whether cisplatin, which is the standard-of-care in COG, can be replaced with a less toxic alternative platin analogue, carboplatin. The standard risk arm will be divided into 2 age-based strata: (1) Standard Risk 1 (SR1) arm, which includes patients up to 11 years of age with COG Stage II - IV ovarian, testicular or extragonadal GCT and (2) Standard Risk 2 (SR2) arm, which includes patients between 11 and 25 years of age with COG Stage II III (FIGO Stage IC, II and III) ovarian, COG Stage II extragonadal and testicular, COG Stage II IV with IGCCC good risk disease. SR1 patients will be randomized to receive either 4 cycles of PEb (cisplatin, etoposide and bleomycin) or 4 cycles of CEb (carboplatin, etoposide and bleomycin). SR2 patients will be randomized to receive either 3 cycles of BEP (cisplatin, etoposide and bleomycin) or 3 cycles of BEC (carboplatin, etoposide and bleomycin). Bleomycin will be administered once per cycle for a total of 4 doses in SR1 patients versus weekly for a total of 9 doses in SR2 patients. Several corollary studies, including evaluation of toxicities (including patient-reported outcomes), pharmacogenetic analysis of adverse events, evaluation of a new miRNA diagnostic and prognostic test and molecular pathway analysis of pediatric, adolescent and young adult GCT are important components of this clinical trial.

Clinical Trial

Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors

This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Clinical Trial

Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery

This partially randomized phase II/III trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy after surgery may kill more tumor cells.

Clinical Trial

POE16-01, A study of neratinib in children and adolescent and young adults with relapsed/refractory solid tumors or leukemias

This is a multi-center, open label, phase I/II trial evaluating the safety and efficacy of neratinib in pediatric patients with relapsed/refractory malignancies. This trial is an investigator initiated trial managed by the Pediatric Oncology Experimental Therapeutics Investigator s Consortium (POETIC), which will hereafter be referred to as the Sponsor. In the phase I portion, the primary objective will be to determine the dose limiting toxicity (DLT), the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for neratinib in pediatric patients with relapsed/refractory malignancies. There will be 2 cohorts of patients, which will accrue separately: Cohort 1 will consist of patients with solid tumors including lymphoma and central nervous system (CNS) malignancies, and will accrue first. Cohort 2 will consist of patients with relapsed/refractory acute leukemia. Once an MTD has been determined in Cohort 1, Cohort 2 will begin enrolling with a limited dose-escalation design at the MTD found in cohort 1. Additionally, an interim analysis will be performed after the completion of enrollment of Cohort 1 at which time the toxicity profile, PK and PD data will be reviewed to establish confidence regarding the RP2D to be used for the starting dose of the leukemia cohort and for subsequent dosing of solid tumor patients. A rolling six dose escalation schema will be used with 3-6 subjects enrolled per dose level for both cohorts. Patients are recommended to be admitted for the first 7 days of Cycle 1 to monitor for diarrhea. If the patient is treated in an outpatient setting, they must be seen every 48- 72hours. Patients must be able to swallow tablets for eligibility onto the study. Neratinib will be administered once a day either by mouth or via a pre-existing permanent gastrostomy tube. Each cycle will consist of 28 days. There will be no interruption of dosing between Day 28 of Cycle 1 and Day 1 of Cycle 2. Dose escalation is detailed in Appendix 2 and will continue until MTD and RP2D is established. There will be no intra-patient dose escalation. It is anticipated that the phase I part for Cohort 1 will be completed in 1 year. The phase I part for Cohort 2 is anticipated to take less than a year to accrue since these patients will utilize a limited doseescalation schema and will start accrual either at the MTD identified for Cohort 1 or, if unacceptable toxicity is noted at the MTD in the interim analysis, one dose level below. We anticipate accruing 9-12 patients in Cohort 2. The expected accrual for the phase 1 component is 18-30 patients overall. Once the MTD is established in Cohort 1, the phase II portion of the study will open for accrual for solid tumors (including lymphoma and CNS malignancies) at the RP2D following a Simon two stage design. These patients will accrue simultaneously with the accrual of Cohort 2 patients to the phase I portion. Once the MTD for Cohort 2 is identified, this dose level will be moved into the phase II part of the study for leukemia patients only. The phase II part is expected to accrue 12-29 patients over the course of 1.5 years, with the leukemia patients expected to enter this phase while accrual for solid tumor is already occurring.