Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (Pediatric MATCH)
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Tazemetostat in Patients With Tumors Harboring Alterations in EZH2 or Members of the SWI/SNF Complex
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Clinical Trial Information
Trial Contact: Spinelli, Jennifer; Leffin, Melissa; El-Shami, Jessica
Trial Phone: 321.841.5357 ; 321.841.2008 ; 321.841.3837
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IRB No: APEC1621C
Protocol Abbrev: APEC1621C
Principal Investigator: Amy A Smith, MD
Phase: Drug: Phase II
Age Group: Adult;Pediatric
Secondary Protocol No: APEC1621C
Treatment: Drug: Tazemetostat
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT03213665
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Objective
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
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Key Eligibility
Ages Eligible for Study: 12 Months to 21 Years (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
