Study on Temozolomide With or Without Veliparib for Newly Diagnosed Glioblastoma Multiforme
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02152982
This clinical trial is exploring whether adding the drug veliparib to the standard chemotherapy drug temozolomide can improve treatment outcomes for patients with newly diagnosed glioblastoma multiforme, a type of brain cancer.
Patient Parameters
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Program Overview
The purpose of this study is to determine if combining the drug veliparib with the standard chemotherapy drug temozolomide is more effective than using temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme, a type of aggressive brain cancer. Temozolomide works by stopping cancer cells from growing, while veliparib may block certain enzymes needed for cancer cell growth. The study aims to find out if this combination can help patients live longer and if it can better control the cancer's progression.
Description
The main goal of this study is to see if adding veliparib to temozolomide can help patients with newly diagnosed glioblastoma multiforme live longer compared to using temozolomide alone. Researchers also want to know if this combination can delay the cancer from getting worse and if it can shrink the tumors more effectively. Additionally, the study will look at whether the combination causes more severe side effects.
Participants in the study will be randomly assigned to one of two groups. One group will receive temozolomide and a placebo (a pill with no active drug), while the other group will receive temozolomide and veliparib. Both groups will take their assigned medications in cycles, with treatment repeating every 28 days for up to 6 cycles, as long as the cancer does not progress or cause unacceptable side effects.
After completing the treatment, participants will have follow-up visits every 3 months for the first 3 years and every 6 months for the next 2 years to monitor their health and the cancer's status.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of newly diagnosed glioblastoma or gliosarcoma, a type of brain cancer.
- Must have enough tumor tissue available for testing.
- Tumor must show a specific genetic marker (MGMT promoter hypermethylation) as determined by central testing.
- Must have good blood cell counts and organ function based on recent blood tests.
- Must be in relatively good overall health, with a performance status score of 0 to 2.
- Must have completed standard radiation and temozolomide therapy before joining the study.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study.
- Must not have any uncontrolled medical conditions, such as seizures or recent blood clots.
- Must not have had major surgery within 14 days before joining the study.
- Must not have a history of certain blood disorders or other specific medical conditions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Kaiser Permanente-Deer Valley Medical Center | 94531 | Antioch | California |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | 91505 | Burbank | California |
| Mills-Peninsula Medical Center | 94010 | Burlingame | California |
| John Muir Medical Center-Concord | 94520 | Concord | California |
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