Veliparib + Radiation + Temozolomide for Brain Cancer

Recruiting at172 trial locations

Overseen by Matthias A Karajannis

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

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

My kidney function, measured by creatinine clearance or GFR, is normal or above.

My bilirubin levels are within the normal range for my age.

I am between 3 and 21 years old.

Exclusion Criteria

I have been diagnosed with gliomatosis cerebri type 1 or 2.

I am currently pregnant.

I am sexually active and capable of having children.

Treatment Details

Interventions

• Radiation Therapy (Radiation)
• Temozolomide (Alkylating Agent)
• Veliparib (PARP Inhibitor)

Trial Overview The study tests the effectiveness of veliparib combined with radiation therapy and temozolomide in treating malignant glioma. Veliparib is a PARP inhibitor that may prevent tumor cells from repairing DNA damage, potentially enhancing the effects of chemotherapy and radiation.

Participant Groups

Group I: Treatment (radiation therapy, veliparib, temozolomide) Experimental Treatment 3 Interventions

CHEMORADIOTHERAPY PHASE: Patients receive veliparib PO BID and undergo 30 daily fractions of radiation therapy 5 days per week for 6-7 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE CHEMOTHERAPY: Beginning 4 weeks after chemoradiotherapy phase, patients receive veliparib PO BID and temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.

Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School