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Telaglenastat + Radiation Therapy + Temozolomide for Astrocytoma

Phase 1

Waitlist Available

Led By Sani H Kizilbash

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histopathologic or molecular confirmation of either IDH-mutant DA or IDH-mutant AA. Acceptable IDH mutations for study eligibility include any IDH1 mutation at codon 132 or any IDH2 mutation at codon 172.

If there is history of hepatitis C virus (HCV) infection, patients must have been treated and HCV viral load must be undetectable.

Must not have

No prior use of Gliadel wafers.

Pregnant women are excluded from this study because telaglenastat (CB-839) HCl is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with telaglenastat (CB-839) HCl, breastfeeding should be discontinued if the mother is treated with telaglenastat (CB-839) HCl. These potential risks may also apply to TMZ.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of telaglenastat, radiation therapy, and chemotherapy in treating patients with brain tumors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to enzyme inhibition by telaglenastat which could affect cell growth, typical chemotherapy-related issues such as nausea and hair loss from temozolomide, and risks associated with radiation therapy like skin irritation or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has a specific IDH mutation.

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I had hepatitis C but have been treated and now have no detectable virus.

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I have chronic hepatitis B but it's under control or undetectable.

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I am mostly self-sufficient and can carry out daily activities.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never used Gliadel wafers.

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I am not pregnant or breastfeeding.

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

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My cancer has not spread to my brain's lower part or spine.

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I have not had chemotherapy for my brain tumor.

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I cannot swallow pills.

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I am a young person who needs sedation for MRI or MRS scans.

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I am allergic to medications similar to telaglenastat or TMZ.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)

Secondary study objectives

Assessment of neurocognitive impact

Assessment of pharmacokinetic (PK) parameters

Assessment of plasma oncometabolites

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Temozolomide

2010

Completed Phase 3

~1880