Current Research Trials

Oncology Clinical Trials

Registry and Biology Protocols

• Project:EveryChild A Registry, Eligibility Screening, Biology and Outcome Study:
• Neuroblastoma Biology Studies
• Renal Tumors Classification, Biology and Banking Study

Acute Lymphoblastic Leukemia (ALL) Protocols

• A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway–Mutant Acute Lymphoblastic Leukemia
• International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Ph+ ALL Testing Imatinib in Combination with Two Different Cytotoxic Chemotherapy Backbones
• A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)
• A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-Lly -HR-BALL
• A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC# 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to <31 Years Old with First Relapse
• Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia (AML) Protocols

• Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome
• A phase 3 randomized trial for patients with de novo AML comparing standard therapy including gemtuzumab ozogamicin GO to CPX-351 with GO, and the addition of the FLT3 inhibitor gilteritinib for patients with FLT3 mutations

Central Nervous System (CNS) Protocols

• A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients
• A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)
• A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
• A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Hodgkins Disease Protocols

• A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma)
• A Randomized Phase 3 trial of Nivolumab (NSC#748726 IND#125462) in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

Non-Sarcoma Solid Tumor Protocols

• 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
• A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors – ANZUP Trial
• Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)
• Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma
• A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive Neuroblastoma
• A Randomized Phase 2 Trial of Axitinib/Nivolumab combination therapy vs single agent Axitinib or Nivolumab for the treatment of TFE/Translocation Renal Cell Carcinoma across all age groups

Sarcoma Protocols

• A Safety, Pharmacokinetic and Efficacy Study of a Gamma-Secretase Inhibitor, Nirogacestat (PF-03084014; IND# 146375), in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors
• Larotrectinib (LOXO-101, NSC# 788607, IND# 141824) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Cancer Control and other Non-Therapeutic Protocols

• Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study
• Umbrella Long-Term Follow-Up Protocol
• Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children with Cancer
• Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy
• Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma
• StepByStep: A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention among AYA Cancer Survivors
• Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

Molecular and Pharmacokinetic Protocols

• NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) – Phase 2 subprotocol of LOXO-101 in patients with tumors harboring actionable NTRK fusions.
• NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 subprotocol of Ensartinib in patients with tumors harboring ALK or ROS1 genomic alterations
• NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) – Phase 2 Subprotocol of Palbociclib in Patients with Tumors Harboring Activating Alterations in Cell Cycle Genes
• NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 subprotocol of Tipifarnib in patients with tumors harboring HRAS genomic alterations
• NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) – Phase 2 Subprotocol of LOXO-292 in Patients with Tumors Harboring RET Gene Alterations
• NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice Master Version) Screening Protocol
• NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice Master Version) Control Document
• A Phase I/II, Multicenter, Open-Label, Multi-Arm Study Evaluating The Safety Toleraility, Pharmacokinetics, And Preliminary Activity of Idasanutlin Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemias or Solid Tumors
• Phase I study of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias