Study on Vorasidenib for Patients with Residual or Returning Grade 2 Glioma with IDH1 or IDH2 Mutation
Sponsor: Institut de Recherches Internationales Servier
ClinicalTrials ID:NCT04164901
This clinical trial is testing the effectiveness of the drug vorasidenib compared to a placebo in patients with Grade 2 glioma that has returned or remains after surgery. The study focuses on tumors with specific genetic mutations (IDH1 or IDH2) and involves taking the medication orally.
Patient Parameters
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Program Overview
This study is designed to compare the effects of the drug vorasidenib with a placebo in patients who have Grade 2 glioma, a type of brain tumor, that has either returned or is still present after surgery. The trial is for patients whose tumors have specific genetic mutations known as IDH1 or IDH2. Participants will be randomly assigned to receive either vorasidenib or a placebo, and the study aims to see if vorasidenib can help manage the tumor better than the placebo.
Eligibility Criteria
Inclusion Criteria
- Be at least 12 years old and weigh at least 40 kg (about 88 pounds).
- Have a diagnosis of Grade 2 oligodendroglioma or astrocytoma, which are specific types of brain tumors.
- Have had at least one surgery to remove the tumor, with the last surgery being between 1 and 5 years ago.
- Have not received any other cancer treatments like chemotherapy or radiation.
- Have a confirmed IDH1 or IDH2 gene mutation in the tumor.
- Have a tumor that can be measured by MRI and does not show enhancement.
- Have a good performance status, meaning you can carry out daily activities with little or no assistance.
Exclusion Criteria
- Have received any cancer treatment other than surgery for the glioma, such as chemotherapy, radiation, or experimental drugs.
- Have high-risk features like tumor involvement in the brainstem, significant functional or cognitive issues due to the tumor, or uncontrolled seizures that affect daily life despite trying multiple medications.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35294 | Birmingham | Alabama |
| City of Hope | 91010 | Duarte | California |
| University of California San Diego | 92093 | La Jolla | California |
| UCLA Oncology Center | 90095 | Los Angeles | California |
| University of California Irvine - Hospital | 92868 | Orange | California |
| University of California San Francisco | 94143 | San Francisco | California |
| Stanford Cancer Center | 94305 | Stanford | California |
| University of Colorado Hospital - Anschutz Cancer Pavilion | 80045 | Aurora | Colorado |
| Yale University, Yale Cancer Center | 06510 | New Haven | Connecticut |
| Mayo Clinic Jacksonville | 32224 | Jacksonville | Florida |
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