Tazemetostat for Solid Cancers and Lymphoma

Recruiting at 122 trial locations

Overseen by Susan N Chi

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies how well tazemetostat works in children with certain difficult-to-treat cancers that have specific gene mutations. Tazemetostat is a pill that aims to stop cancer cell growth by blocking a specific protein. The goal is to see if this treatment can help these children when other treatments have failed. Tazemetostat is already approved for treating various cancers, including certain brain tumors in children.

Research Team

Susan N Chi

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for patients with relapsed or refractory advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with specific gene mutations (EZH2, SMARCB1, SMARCA4). Participants must have measurable disease and recovered from previous cancer therapies. They need adequate blood counts and organ function and can't have had prior EZH2 inhibitor treatment.

Inclusion Criteria

My cancer can be seen and measured on scans, or if I have neuroblastoma, it shows up on special scans even if not measurable.

My blood counts meet the required levels and I haven't needed platelet transfusions in the last week.

My kidney function is normal or near normal.

Exclusion Criteria

My blood tests do not show signs of specific blood disorders.

I do not have any infections that are currently uncontrolled.

Pregnant or breast-feeding women

Treatment Details

Interventions

• Tazemetostat (EZH2 Inhibitor)

Trial Overview The trial tests Tazemetostat's effectiveness in stopping tumor growth by blocking a protein called EZH2. It targets patients whose cancers haven't responded to other treatments and who carry certain genetic mutations that may be affected by this drug.

Participant Groups

Group I: Treatment (tazemetostat) Experimental Treatment 1 Intervention

Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Children's Oncology Group

Collaborator

Trials

467

Recruited

241,000+

Dr. Doug Hawkins

Children's Oncology Group

Chief Executive Officer since 2020

MD from University of Washington School of Medicine

Dr. Leo Mascarenhas

Children's Oncology Group

Chief Medical Officer since 2024

MD, MS from Cedars-Sinai Guerin Children’s