Veliparib + Radiation + Temozolomide for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a combination of treatments against malignant glioma, an aggressive brain cancer. It uses veliparib, a drug that prevents cancer cells from repairing themselves, alongside radiation therapy and the chemotherapy drug temozolomide. The aim is to determine if this combination is more effective than using only radiation therapy and temozolomide. Individuals newly diagnosed with high-grade glioma and specific genetic profiles (without H3 K27M or BRAFV600 mutations) may be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both veliparib and temozolomide have undergone safety testing in humans. Studies have found that veliparib, when combined with radiation, is well-tolerated in cases involving brain conditions. Specifically, it can be safely used with radiation therapy in patients with brain metastases. Veliparib works by preventing tumor cells from repairing themselves, potentially stopping their growth.
Temozolomide is a well-known chemotherapy drug for treating brain tumors. It has been widely studied and is considered safe, though it can cause side effects. Studies have noted side effects such as issues with blood cells, but it remains in use due to its effectiveness in treating tumors.
Overall, both veliparib and temozolomide have demonstrated safety in human studies, despite some known side effects. Testing the safety of any new combination, such as in this trial, underscores the importance of further studies.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of veliparib, radiation, and temozolomide for brain cancer because this treatment approach targets cancer cells in a unique way. Veliparib is a PARP inhibitor, which interferes with cancer cells' ability to repair their DNA, making them more susceptible to damage from radiation. This combination could enhance the effectiveness of radiation therapy and temozolomide, potentially improving outcomes compared to standard treatments. While traditional treatments often focus solely on killing cancer cells directly, this approach weakens cancer cells' defenses, potentially leading to better control of tumor growth.
What evidence suggests that this trial's treatments could be effective for brain cancer?
This trial will evaluate the combination of temozolomide, radiation therapy, and veliparib for brain cancer. Studies have shown that combining temozolomide with radiation therapy can extend the lives of brain cancer patients. For instance, one study found that 70% of patients survived for 10 years with this combined treatment, compared to 47% with just radiation. Temozolomide has significantly increased the average survival time for brain tumor patients.
Research on veliparib, a PARP inhibitor, suggests it may prevent tumor cells from repairing themselves, potentially stopping their growth. However, several studies found that adding veliparib to treatments like temozolomide did not significantly increase survival for certain types of brain cancer. While veliparib's method shows promise, its ability to extend life for brain cancer patients remains unproven. Participants in this trial will receive the combination of radiation therapy, temozolomide, and veliparib to further investigate its potential benefits.16789Who Is on the Research Team?
Matthias A Karajannis
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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