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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorAlliance for Clinical Trials in Oncology

About this trial

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.

Eligibility criteria

Qualifiers

STEP 0: Histologic diagnosis of astrocytoma, IDH-mutant (central nervous system [CNS] WHO grade 3)

STEP 0: Available diagnostic slides (hematoxylin and eosin staining method [H&E] and immunohistochemical stains for central review)

STEP 0: Tissue available for central biomarker testing (CDKN2A/B and1p/19q co-deletion [all patients], and IDH1/IDH2 [if needed])

STEP 1: Centrally-confirmed diagnosis of astrocytoma, IDH-mutant (CNS WHO grade 3)

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Intensity-Modulated Radiation Therapy
  • Volume Modulated Arc Therapy
  • Pencil Beam Scanning
  • Intensity-Modulated Proton Therapy
  • Temozolomide
  • Vorasidenib
  • Placebo Administration
  • Biospecimen Collection
  • Magnetic Resonance Imaging
  • Questionnaire Administration

Treatment groups

408 Participants
are divided into 2 treatment groups

Locations

82
California
City of Hope Comprehensive Cancer Center91010, Duarte United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care92612, Irvine United States
UC Irvine Health/Chao Family Comprehensive Cancer Center92868, Orange United States
University of California Davis Comprehensive Cancer Center95817, Sacramento United States

Sponsors and collaborators

Alliance for Clinical Trials in Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator