Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma (NCT01480050) | Clinical Trial Compass
CompletedPhase 1
Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma
United States28 participantsStarted 2012-05-31
Plain-language summary
RATIONALE: Mibefradil dihydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the best dose of mibefradil dihydrochloride when given together with temozolomide in treating patients with glioma.
Who can participate
Age range
18 Years – 120 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.
ELIGIBILITY CRITERIA
* Subjects must be 18 years of age or older.
* Subjects must have histologically proven high-grade glioma (glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, mixed anaplastic oligoastrocytoma, anaplastic ependymoma) that is progressive or recurrent following standard upfront radiation therapy + temozolomide.
* Subjects must have measurable contrast-enhancing progressive or recurrent high grade glioma (single or multiple lesions) by MRI within 30 days of starting treatment.
* Subject must be able to tolerate MRIs. CT scans cannot be substituted for MRIs in this study.
\* Dose Expansion Subjects Only: the area of contrast enhancement must be at least 1 cm in short axis dimension.
* Subjects must have recovered to CTCAE grade \<2 from toxicities related to prior therapy. An interval of at least 3 months must have elapsed since the completion of the most recent course of radiation therapy, the last dose of temozolomide (TMZ), or placement of Gliadel wafers. No prior cytotoxic therapies other than temozolomide and Gliadel wafers are allowed. Prior anti-VEGF therapies are allowed if more than four months have elapsed from the end of prior treatment. 30 days must have elapsed since previous treatment of the brain tumor with any other agents.
* Subjects must have a plan for retreatment with temozolomide at 150-200 mg/m2 for 5-days per cycle; each cycle = 28 days. Subjects must have previously tolerated at least one cycle of adjuvant temozolom…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Maximum-tolerated dose of mibefradil dihydrochloride
Timeframe: 2 years
2
Dose-limiting toxicity
Timeframe: 2 years
Trial details
NCT IDNCT01480050
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins