Testing the Addition of Vorasidenib to Temozolomide After Radiation for Advanced Brain Cancer
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT07215910
This study is exploring whether adding the drug vorasidenib to the usual treatment with temozolomide can improve outcomes for patients with newly diagnosed grade 3 astrocytoma, a type of brain cancer, after they have received radiation therapy.
Patient Parameters
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Program Overview
This phase III clinical trial is investigating if adding vorasidenib to the standard treatment with temozolomide can be more effective in treating patients with newly diagnosed grade 3 astrocytoma after radiation therapy. Temozolomide is a chemotherapy drug that works by damaging the DNA of cancer cells, which may help kill them or slow their growth. Vorasidenib is a targeted therapy that blocks certain proteins made by mutated genes, potentially stopping tumor growth. The study aims to see if this combination can improve patient outcomes compared to using temozolomide alone.
Description
The main goal of this study is to see if adding vorasidenib to temozolomide after radiation therapy can help patients with newly diagnosed IDH-mutant grade 3 astrocytoma live longer without their cancer getting worse. Researchers will also look at the safety of this combination and how it affects patients' quality of life.
Participants will be randomly assigned to one of two groups. One group will receive the standard treatment of radiation followed by temozolomide and a placebo. The other group will receive radiation followed by temozolomide and vorasidenib. Both groups will have regular blood tests and MRI scans to monitor their health and the cancer's response to treatment.
After finishing the treatment, participants will have follow-up visits every few months for up to 10 years to check on their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with grade 3 astrocytoma with a specific genetic mutation (IDH-mutant).
- Must have tissue samples available for testing.
- No previous treatments like chemotherapy or radiation for this cancer.
- Planned to receive radiation and chemotherapy.
- Aged 12 years or older.
- In good general health with specific blood counts and organ function levels.
- Not pregnant or breastfeeding, and willing to use effective birth control.
- No severe illnesses or infections.
- Able to undergo MRI scans.
- No significant heart disease or other serious medical conditions.
- No allergies to the study drugs.
- Not using other experimental treatments or certain medications that could interfere with the study.
Exclusion Criteria
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Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | 92612 | Irvine | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Yale University | 06520 | New Haven | Connecticut |
| Smilow Cancer Hospital Care Center-Trumbull | 06611 | Trumbull | Connecticut |
| Smilow Cancer Hospital Care Center - Waterford | 06385 | Waterford | Connecticut |
| Helen F Graham Cancer Center | 19713 | Newark | Delaware |
| Medical Oncology Hematology Consultants PA | 19713 | Newark | Delaware |
| OSF Saint Joseph Medical Center | 61701 | Bloomington | Illinois |
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