Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas (NCT00268385) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas
United States83 participantsStarted 2005-12-16
Plain-language summary
This phase I trial is studying the side effects and best dose of vorinostat when given together with temozolomide in treating patients with malignant gliomas. Drugs used in chemotherapy, such as vorinostat and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may help temozolomide work better by making tumor cells more sensitive to the drug. Giving vorinostat together with temozolomide may kill more tumor cells.
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:
* Patients with histologically proven intracranial malignant glioma will be eligible for this protocol; malignant gliomas include glioblastoma multiforme (GBM), gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified); patients will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of a malignant glioma is made
* All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must have signed an authorization for the release of their protected health information; patients must be registered with the Adult Brain Tumor Consortium (ABTC) Central Office database prior to treatment with study drug
* Life expectancy \> 8 weeks
* Karnofsky performance status of \>= 60
* White blood cell (WBC) \>= 3,000/mm\^3
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 10 g/dL; eligibility level for hemoglobin may be reached by transfusion
* Serum glutamic oxaloacetic transaminase (SGOT) \< 2 times upper limit of normal (ULN)
* Bilirubin \< 2 times ULN
* If liver function tests are above the institutional upper limit of normal but \< 2 times institutional upper limit of normal, the decision to initiate temozolomide treatment should carefully consider the benefits and risks for the individual p…
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.
1Since this is a Phase 1 trial focused on finding the maximum tolerated dose of vorinostat combined with temozolomide, what does that mean for what's actually known so far about whether this combination is effective against my type of glioma?
2The trial is measuring dose-limiting toxicity — what kinds of serious side effects have been seen with this vorinostat and temozolomide combination, and how would those affect my day-to-day functioning?
3Since the trial is active but no longer recruiting, is there any chance I could still be considered for enrollment, or should we focus our energy on other options?
4Given that my diagnosis is a recurrent or malignant glioma, would standard temozolomide alone or another established treatment be a more appropriate first step before considering an experimental combination like this?
5If I'm not eligible for this trial or it's fully closed, are there other Phase 2 or Phase 3 trials studying vorinostat or similar HDAC inhibitors for my specific type of glioma that might have more safety data behind them?
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.
What they're measuring
1
MTD of vorinostat with temozolomide defined as the dose at which less than one-third of patients experience dose-limiting toxicity based on the CTC severity grading (Part I)