Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer

Summary

This phase III trial compares the effect of vorasidenib to placebo in combination with usual treatment, temozolomide, in treating patients with newly diagnosed grade 3 astrocytoma after radiation. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Vorasidenib citrate blocks the proteins made by the mutated IDH1 and IDH2 genes, which may help keep tumor cells from growing. It is a type of enzyme inhibitor and a type of targeted therapy. Adding vorasidenib to the usual treatment, temozolomide, may be more effective than temozolomide alone in treating patients with newly diagnosed grade 3 astrocytoma after radiation therapy.

Conditions

• Astrocytoma, IDH-Mutant, Grade 3

Interventions

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT/VMAT

RADIATION

Volume Modulated Arc Therapy

Undergo IMRT/VMAT

RADIATION

Pencil Beam Scanning

Undergo PBS

PROCEDURE

Intensity-Modulated Proton Therapy

Undergo IMPT

DRUG

Temozolomide

Given PO

DRUG

Vorasidenib

Given PO

DRUG

Placebo Administration

Given PO

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Questionnaire Administration

Ancillary Studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• Ugonma N Chukwueke, MD · Alliance for Clinical Trials in Oncology

• Rifaquat M. Rahman, MD · Alliance for Clinical Trials in Oncology

• Patrick Y Wen, MD · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-20

Primary Completion

2033-05-31

Completion

2040-01-31