Recruiting PHASE3 Astrocytoma, IDH-Mutant, Grade 3

New treatment option for Astrocytoma, IDH-Mutant, Grade 3

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

ClinicalTrials.gov ID: NCT07215910

What this study is testing

What is Temozolomide?

Temozolomide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for astrocytoma, idh-mutant, grade 3.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: 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.

Phase 3: a large, late-stage study
Time commitment: about 10 years
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 12 and older

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...

See the full eligibility criteria

Who can join

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...
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)
STEP 1: Not pregnant and not nursing, because this study involves agents whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown \ Therefore, for women of childbearing...
STEP 1: Women and men of reproductive potential should agree to abstain from sexual intercourse or use two highly effective methods of birth control, at least one of which must be a barrier method, throughout their...
STEP 1: No severe or intercurrent illness, no active infection that requires systemic anti-infective therapy, and no active infection with an unexplained fever \> 38.5°C within 7 days prior to registration
STEP 1: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are...
STEP 1: Patients must be able to tolerate or undergo an MRI
STEP 1: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
STEP 1: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
STEP 1: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
STEP 1: No significant active cardiac disease within 6 months prior to registration, including New York Heart Association Functional Classification class III or IV congestive heart failure, myocardial infarction...
STEP 1: No history of significant (grade ≥ 2) intratumoral or peri-tumoral hemorrhage
STEP 1: No known active inflammatory gastrointestinal disease, chronic diarrhea, prior gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition causing an inability to swallow oral...
STEP 1: No known hypersensitivity to any of the components of vorasidenib or temozolomide
STEP 1: No other acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or protocol therapy administration or may interfere with the interpretation of...
STEP 1: No concurrent use of other investigational agents
STEP 1: No concurrent use of alternating tumor treating field (TTField) therapy
STEP 1: No concurrent use of therapeutic doses of steroids for glioma. Concurrent use of physiologic doses of steroids (defined as equivalent of ≤ 10 mg prednisone daily) for medical conditions unrelated to glioma is...
STEP 1: No concurrent use of warfarin sodium or any other Coumadin-derivative anticoagulant. Patients must be off Coumadin-derivative anticoagulants for at least 7 days prior to registration. Low molecular weight...
STEP 1: No concurrent use of strong and moderate CYP1A2 inhibitors, moderate CYP1A2 inducers, or CYP3A substrates where a minimal concentration change can reduce how well it works. Patients should be transferred to...

The study team makes the final eligibility decision.

Where it's taking place

Duarte, California, United States
Irvine, California, United States
Orange, California, United States
Sacramento, California, United States
New Haven, Connecticut, United States
Trumbull, Connecticut, United States
Waterford, Connecticut, United States
Newark, Delaware, United States
Bloomington, Illinois, United States
Canton, Illinois, United States
Carthage, Illinois, United States
Chicago, Illinois, United States
Eureka, Illinois, United States
Evanston, Illinois, United States
Galesburg, Illinois, United States
Glenview, Illinois, United States
Highland Park, Illinois, United States
Kewanee, Illinois, United States
Macomb, Illinois, United States
Ottawa, Illinois, United States

+ 50 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Duarte, California, United States; Irvine, California, United States; Orange, California, United States; Sacramento, California, United States; New Haven, Connecticut, United States; Trumbull, Connecticut, United States and 64 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.