A new clinical trial led by the Oncology Clinical Trials Alliance will investigate whether combination drug therapy after radiation therapy improves outcomes for patients newly diagnosed with grade 3 IDH-mutant astrocytoma, a type of brain tumor. The study (Alliance A072301), supported in part by a grant from the National Cancer Institute, will examine whether adding the oral drug vorasidenib to standard oral chemotherapy can prevent cancer recurrence after radiation therapy.
People diagnosed with IDH-mutated grade 3 astrocytoma usually undergo surgery, followed by radiation therapy and the oral chemotherapy drug temozolomide. Temozolomide works by damaging the DNA of tumor cells, making them unable to continue growing. However, tumors tend to progress after treatment, especially if the patient has a genetic mutation in IDH1 or IDH2.
Vorasidenib is a newer brain-penetrating targeted drug designed to block the proteins made by these mutated IDH genes. By blocking this abnormal growth signal, researchers hope that adding vorasidenib will kill all cancer cells. This trial will study whether the combination of vorasidenib and temozolomide is more effective than temozolomide alone.
IDH-mutant grade 3 astrocytomas are a serious condition, and many of these tumors recur even after aggressive upfront treatment. By adding new targeted therapies that target the underlying IDH mutations, this study may help identify more effective options for patients with this type of brain tumor, a long-standing unmet need in the field. If successful, vorasidenib could become the first widely used IDH-targeted drug added to standard of care in this patient population. ”
Ugonma Chukwueke, MD, MPH, Alliance Research Chair and Neuro-Oncologist, Dana-Farber Cancer Institute, Boston
Study participants will be randomly assigned to one of two groups:
- Standard arm: Radiation therapy was followed by 1 year of temozolomide and placebo, followed by placebo alone.
- Intervention arm: Radiation therapy was followed by temozolomide and vorasidenib for 1 year, then vorasidenib alone.
All participants in the trial will receive regular follow-up care, including MRI scans, regular blood tests, and visits from their treatment team.
The researchers aim to understand several important results of this study, including how long patients can remain stable without their tumors growing (a measure known as progression-free survival). They also plan to evaluate overall survival, or how long patients live after receiving treatment, to understand the broader impact of adding vorasidenib to standard treatment. Another important focus is the safety and side effect profile of combining vorasidenib with temozolomide after radiotherapy, ensuring that this combination is effective and tolerable for patients.
The study aims to recruit approximately 400 people ages 12 and older who are newly diagnosed with grade 3 astrocytoma at cancer centers across the United States.
Alliance A072301: For more information on a Phase 3 trial of the IDH inhibitor vorasidenib in combination with placebo followed by adjuvant temozolomide for newly diagnosed grade 3 astrocytomas due to IDH mutations, visit ClinicalTrials.gov.
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Alliance for Clinical Trials in Oncology
