Last updated on August 2019

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)


Brief description of study

This phase II Pediatric MATCH trial studies how well tazemetostat 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 and have EZH2, SMARCB1, or SMARCA4 gene mutations. Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Study Description

PRIMARY OBJECTIVES:

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), lymphomas 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.

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.

TERTIARY 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. Courses 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.

Clinical Study Identifier: NCT03213665

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San Jorge Children's Hospital

San Juan, Puerto Rico
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