Telaglenastat + Radiation Therapy + Temozolomide for Astrocytoma

Recruiting in Palo Alto (17 mi)

+24 other locations

Overseen bySani Kizilbash, MD, MPH

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase 1b trial studies the side effects and best dose of telaglenastat in combination with radiation therapy and temozolomide in treating patients with IDH-mutated diffuse or anaplastic astrocytoma. Telaglenastat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving telaglenastat with radiation therapy and temozolomide may work better than surgery, radiation therapy, and temozolomide in treating patients with IDH-mutated diffuse astrocytoma or anaplastic astrocytoma.

Eligibility Criteria

This trial is for patients with IDH-mutated diffuse or anaplastic astrocytoma. They must have certain blood levels, organ function, and no evidence of tumor in the lower brain or spine. Participants need to be over 16 years old, not pregnant, willing to use contraception, and able to give consent. Those with severe illnesses or a second active cancer are excluded.

Inclusion Criteria

My cancer has a specific IDH mutation.

I am on a stable blood thinner dose without bleeding or clotting issues.

Hemoglobin > 9.0 g/dL (within 14 days prior to registration)

+22 more

Exclusion Criteria

I have never used Gliadel wafers.

I am not pregnant or breastfeeding.

I have not had radiation therapy to my brain or overlapping areas of my head and neck.

+11 more

Participant Groups

The trial tests telaglenastat combined with radiation therapy and temozolomide chemotherapy on patients with specific types of brain tumors (astrocytomas). It aims to find the best dose of telaglenastat that's effective when used alongside standard treatments like surgery and radiation.

1Treatment groups

Experimental Treatment

Group I: Treatment (telaglenastat, temozolomide, RT)Experimental Treatment4 Interventions

Patients receive telaglenastat PO BID 7 days a week, temozolomide PO QD 7 days a week, and undergo RT 5 days a week for up to 5.5 weeks (diffuse astrocytoma) or 6.5 weeks (anaplastic astrocytoma) in the absence of disease progression or unacceptable toxicity.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Radiation Therapy for: