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 range18 Years – 120 Years
SexALL
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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…
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