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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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)
• STEP 1: Presence of IDH1 p.R132 or IDH2 p.172 mutation, confirmed by central review of immunohistochemical stain or molecular testing results, with central confirmation of equivocal results
• STEP 1: Absence of CDKN2A/B homozygous deletion by central testing
• STEP 1: Absence of whole arm 1p/19q co-deletion (i.e. intact 1p/19q) by central testing
• STEP 1: No evidence of spinal or leptomeningeal disease
• STEP 1: No prior chemotherapy, cranial irradiation, IDH-inhibitor therapy, radiotherapy, vaccine therapy, small-molecule therapy, or laser ablation
• STEP 1: Prior diagnostic surgery/resection/biopsy ≤ 6 months of registration
• STEP 1: Planned radiotherapy and adjuvant chemotherapy
• STEP 1: Age ≥ 12 years
• STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky performance status [KPS] ≥ 60%)
• STEP 1: Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
• STEP 1: Hemoglobin ≥ 9 g/dL
• STEP 1: Platelet count ≥ 100,000/mm\^3
• STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • For patients with Gilbert syndrome, total bilirubin ≤ 1.0 x ULN
• STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x ULN
• STEP 1: Alkaline phosphatase ≤ 2.5 x ULN
• STEP 1: Creatinine ≤ 2.0 x ULN or calculated (calc.) creatinine clearance > 40 mL/min
  • For patients ≥ 18 years of age, calculated using the Cockcroft-Gault equation. For patients < 18 years of age, calculated using the Bedside Schwartz method:
  • Age: 10 to < 13 years; Maximum Serum Creatinine (mg/dL): 1.2 (male) 1.2 (female)
  • Age: 13 to < 16 years; Maximum Serum Creatinine (mg/dL): 1.5 (male) 1.4 (female)
  • Age: ≥ 16 years; Maximum Serum Creatinine (mg/dL): 1.7(male) 1.4 (female)

+ 18 more criteria — see the full checklist in the app.

Where this trial is running

• City of Hope Comprehensive Cancer Center, Duarte, California, United States
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
• University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
• Yale University, New Haven, Connecticut, United States
• Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, United States
• Smilow Cancer Hospital Care Center - Waterford, Waterford, Connecticut, United States
• Helen F Graham Cancer Center, Newark, Delaware, United States
• Medical Oncology Hematology Consultants PA, Newark, Delaware, United States
• OSF Saint Joseph Medical Center, Bloomington, Illinois, United States
• Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
• Illinois CancerCare-Canton, Canton, Illinois, United States

+ 70 more sites.

Who to contact

Alexandra Alexandra LeVasseur · 773-834-4518 · alevasseur@bsd.uchicago.edu

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07215910.