Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Mul… (NCT02152982) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
United States, Puerto Rico447 participantsStarted 2014-12-15
Plain-language summary
This randomized phase II/III trial studies how well temozolomide and veliparib work compared to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologic documentation: newly diagnosed World Health Organization (WHO) grade IV intracranial glioblastoma or gliosarcoma; GBM with oligodendroglial features are NOT PERMITTED in this study if they are 1p19q codeleted; sites submitting GBM with oligodendroglial features will be asked to provide results of 1p/19q codeletion status
* Sufficient tissue available for central pathology review and MGMT methylation status evaluation
* Patients who have had a local MGMT testing that is unmethylated are not allowed to participate
* Tumor MGMT promoter hypermethylation determined by central testing at MD Anderson
* Confirmation by central pathology review of WHO grade IV glioblastoma or gliosarcoma
* Absolute neutrophil count (ANC) \>= 1500 cells/mm\^3 (within 14 days prior to study registration)
* Platelets \>= 100,000 cells/mm\^3 (within 14 days prior to study registration)
* Creatinine =\< 1.5 x upper limit of normal (ULN) (within 14 days prior to study registration)
* Bilirubin =\< 1.5 x ULN (within 14 days prior to study registration; unless patient has Gilbert's disease)
* Alanine aminotransferase (ALT) =\< 3 x ULN (within 14 days prior to study registration)
* Aspartate aminotransferase (AST) =\< 3 x ULN (within 14 days prior to study registration)
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Measurable disease or non-measurable disease; extent of resection: patients with complete resection, partial resection, or biopsy are elig…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 2/3 and is measuring overall survival — what do the results so far suggest about whether adding veliparib to temozolomide is actually helping people live longer compared to temozolomide alone?
2Since the trial is no longer recruiting, is there any published or interim data my care team has access to that could inform whether this combination might still be worth considering as part of my treatment plan?
3How does the veliparib-plus-temozolomide combination in this trial compare to the current standard of care for newly diagnosed glioblastoma, and would you recommend I try standard treatment first before exploring options like this?
4Temozolomide is already part of standard glioblastoma treatment — does adding veliparib come with meaningful extra side effects I should weigh, especially given how demanding glioblastoma treatment already is on daily life?
5Given that this trial was specifically for newly diagnosed glioblastoma and gliosarcoma, does my specific diagnosis and tumor profile make me a good or poor candidate for the type of treatment being studied here?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.