Study on Veliparib, Radiation Therapy, and Temozolomide for Treating Newly Diagnosed Malignant Glioma Without Specific Mutations
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03581292
This clinical trial is testing a combination of veliparib, radiation therapy, and temozolomide to see if it can better treat patients with newly diagnosed malignant glioma that does not have certain genetic mutations.
Patient Parameters
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Program Overview
The study aims to find out if adding the drug veliparib to standard treatments like radiation therapy and temozolomide can improve outcomes for patients with newly diagnosed malignant glioma that lacks H3 K27M or BRAFV600 mutations. Veliparib is a type of drug that stops cancer cells from repairing themselves, potentially making them more vulnerable to treatment. Radiation therapy uses high-energy rays to kill cancer cells, while temozolomide is a chemotherapy drug that stops cancer cells from growing and spreading. The combination of these treatments may be more effective than radiation and temozolomide alone.
Description
The main goal of this study is to see if adding veliparib to radiation therapy and temozolomide is effective for treating patients with high-grade glioma (HGG) who do not have certain genetic mutations. The study will also explore how different genetic changes in tumors might affect treatment outcomes.
During the treatment phase, patients will take veliparib by mouth twice a day and receive radiation therapy five days a week for 6-7 weeks. After this, they will continue taking veliparib and start taking temozolomide for five days every 28 days, for up to 10 cycles, as long as the treatment is working and side effects are manageable.
After finishing the treatment, patients will have follow-up visits every few months to monitor their health and the effectiveness of the treatment. These visits will continue for up to 10 years.
Eligibility Criteria
Inclusion Criteria
- Patients aged 3 to 21 years for Stratum 1 (closed to new participants) and 3 to 25 years for Stratum 2.
- Must have a newly diagnosed high-grade glioma like anaplastic astrocytoma or glioblastoma.
- Tumors must not have H3 K27M or BRAFV600 mutations.
- Must have a confirmed diagnosis through specific medical tests.
- Must not have cancer spread to other parts of the nervous system.
- Must have good overall health and specific blood counts.
- Must have normal kidney and liver function based on blood tests.
- Seizures must be well-controlled if present.
- Must start treatment within 31 days after surgery.
- Must provide informed consent to participate.
Exclusion Criteria
- Cannot have certain types of brain tumors like diffuse astrocytoma or oligodendrogliomas.
- Cannot have tumors in the brainstem or spinal cord.
- Cannot have cancer that has spread to other parts of the nervous system.
- Cannot have had previous treatments like chemotherapy or radiation for the tumor.
- Cannot have certain blood disorders or have had a bone marrow transplant.
- Cannot be pregnant or breastfeeding.
- Must agree to use effective birth control during the study and for six months after treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| USA Health Strada Patient Care Center | 36604 | Mobile | Alabama |
| Banner Children's at Desert | 85202 | Mesa | Arizona |
| Phoenix Childrens Hospital | 85016 | Phoenix | Arizona |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente Downey Medical Center | 90242 | Downey | California |
| Loma Linda University Medical Center | 92354 | Loma Linda | California |
| Miller Children's and Women's Hospital Long Beach | 90806 | Long Beach | California |
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
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