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Clinical Trial

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with olaparib with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating genetic alterations in the deleterious genetic alterations in the DNA damage repair (DDR) pathway.

Clinical Trial

APEC1621B, NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of JNJ-42756493 (Erdafitinib) in patients with relapsed pediatric solid tumors harboring FGFR1/2/3/4 alteration

This phase II Pediatric MATCH trial studies how well erdafitinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment with FGFR mutations. Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Clinical Trial

ACCL10P1: Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study

This randomized clinical trial studies how well an adaptive computerized cognitive training program works compared to a non-adaptive computerized cognitive training program in treating younger patients with brain tumor who underwent radiation therapy. Providing a computer training program may improve the well-being and quality of life of patients with cognitive (physical and mental) function difficulties caused by radiation therapy to the brain.

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, in combination with surgery, cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or hepatocellular carcinoma. 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 may kill more tumor cells than one type of chemotherapy alone.

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

Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)

This phase II Pediatric MATCH trial studies how well ulixertinib works in treating patients with solid tumors that have spread to other places in the body (advanced), non-Hodgkin lymphoma, or histiocytic disorders that have a genetic alteration (mutation) in a signaling pathway called MAPK. A signaling pathway consists of a group of molecules in a cell that control one or more cell functions. Genes in the MAPK pathway are frequently mutated in many types of cancers. Ulixertinib may stop the growth of cancer cells that have mutations in the MAPK pathway

Clinical Trial

GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS

This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.