Veliparib + Radiation + Temozolomide for Brain Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must not be currently receiving other anti-cancer agents.
What data supports the effectiveness of the treatment Veliparib + Radiation + Temozolomide for brain cancer?
What safety data exists for the combination of Veliparib, Radiation, and Temozolomide in treating brain cancer?
The combination of radiation therapy and temozolomide has been studied for brain metastases and high-grade gliomas, showing some common side effects like neutropenia (low white blood cell count), anemia (low red blood cell count), vomiting, fatigue, and dizziness. Serious blood-related side effects were not observed, but skin reactions have been reported in some cases. Overall, the treatment was considered active and improved quality of life in some patients.56789
What makes the Veliparib + Radiation + Temozolomide treatment unique for brain cancer?
This treatment combines Veliparib, a drug that may enhance the effects of radiation, with Temozolomide, a chemotherapy drug that can cross the blood-brain barrier and has shown effectiveness in treating brain tumors. The combination aims to improve the effectiveness of radiation therapy by making cancer cells more sensitive to it, potentially leading to better outcomes for patients with brain cancer.1011121314
What is the purpose of this trial?
This phase II trial studies how well veliparib, radiation therapy, and temozolomide work in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations. Poly adenosine diphosphate (ADP) ribose polymerases (PARPs) are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib, radiation therapy, and temozolomide may work better in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations compared to radiation therapy and temozolomide alone.
Research Team
Matthias A Karajannis
Principal Investigator
Children's Oncology Group
Eligibility Criteria
This trial is for patients with newly diagnosed malignant glioma without certain mutations (H3 K27M or BRAFV600). Eligible participants are between 3-25 years old, have not received prior tumor-directed therapy, and can start treatment within 31 days after surgery. They must have proper organ function and controlled seizures if present.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiotherapy
Patients receive veliparib orally twice daily and undergo 30 daily fractions of radiation therapy 5 days per week for 6-7 weeks
Maintenance Chemotherapy
Patients receive veliparib orally twice daily and temozolomide orally once daily on days 1-5, repeating every 28 days for up to 10 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Radiation Therapy
- Temozolomide
- Veliparib
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor