Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ann Arbor Stage III Hodgkin Lymphoma
- Advanced Malignant Solid Neoplasm
- Ann Arbor Stage III Non-Hodgkin Lymphoma
- Ann Arbor Stage IV Hodgkin Lymphoma
- Recurrent Osteosarcoma
- Recurrent Malignant Solid Neoplasm
- Stage IV Soft Tissue Sarcoma AJCC v7
- Refractory Malignant Solid Neoplasm
- Refractory Non Hodgkin Lymphoma
- Refractory Rhabdoid Tumor
- Refractory Neuroblastoma
- Ann Arbor Stage IV Non-Hodgkin Lymphoma
- Refractory Peripheral Primitive Neuroectodermal Tumor
- Wilm's Tumor
- Recurrent Malignant Germ Cell Tumor
- Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Low Grade Glioma
- Recurrent Langerhans Cell Histiocytosis
- Refractory Medulloblastoma
- Recurrent Peripheral Primitive Neuroectodermal Tumor
- Recurrent Soft Tissue Sarcoma
- Recurrent Malignant Glioma
- Recurrent Non-Hodgkin Lymphoma
- Stage III Soft Tissue Sarcoma AJCC v7
- Recurrent Ependymoma
- Recurrent Hodgkin Lymphoma
- Recurrent Primary Central Nervous System Neoplasm
- Recurrent Rhabdoid Tumor
- Recurrent Ewing Sarcoma
- Refractory Hodgkin Lymphoma
- Refractory Malignant Germ Cell Tumor
- Recurrent Neuroblastoma
- Rhabdoid Tumor
- Refractory Soft Tissue Sarcoma
- Recurrent Glioma
- Recurrent Hepatoblastoma
- Recurrent Rhabdomyosarcoma
- Refractory Malignant Glioma
- Refractory Langerhans Cell Histiocytosis
- Refractory Osteosarcoma
- Recurrent Medulloblastoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 1221 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with tazemetostat with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphoma or histiocytic disorders that harbor gain of fun...
PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with tazemetostat with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphoma or histiocytic disorders that harbor gain of function mutations in EZH2, or loss of function mutations in the SWI/SNF complex subunits SMARCB1 or SMARCA4 at a dose of 520 mg/m^2/dose twice daily for patients without any CNS involvement or 1200 mg/m^2/dose orally twice daily for patients with CNS involvement. SECONDARY OBJECTIVES: I. To estimate the progression-free survival in pediatric patients treated with tazemetostat that harbor gain of function mutations in EZH2, or loss of function mutations in the SWI/SNF complex subunits SMARCB1 or SMARCA4. II. To obtain information about the tolerability of tazemetostat in children with relapsed or refractory cancer. EXPLORATORY OBJECTIVES: I. To evaluate other biomarkers as predictors of response to tazemetostat and specifically, whether tumors that harbor different missense mutations or fusions will demonstrate differential response to tazemetostat treatment. II. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA). OUTLINE: Patients receive tazemetostat orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
Tracking Information
- NCT #
- NCT03213665
- Collaborators
- Children's Oncology Group
- Investigators
- Principal Investigator: Susan N Chi Children's Oncology Group
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