Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma

Phase 1 Completed 28 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Cavion, Inc. · collab National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2012-05-31
Primary completion: 2015-08
Completion: 2017-06-01

Publications

Results Holdhoff M, Ye X, Supko JG, Nabors LB, Desai AS, Walbert T, Lesser GJ, Read WL, Lieberman FS, Lodge MA, Leal J, Fisher JD, Desideri S, Grossman SA, Wahl RL, Schiff D. Timed sequential therapy of the selective T-type calcium channel blocker mibefradil and temozolomide in patients with recurrent high-grade gliomas. Neuro Oncol. 2017 Jun 1;19(6):845-852. doi: 10.1093/neuonc/nox020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	mibefradil	Small molecule	87.5 mg	Oral
Subject	mibefradil	Small molecule	100 mg	Oral
Background	Temozolomide	Small molecule	150 mg/m2	Oral
Background	Temozolomide	Small molecule	200 mg/m2	Oral

Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma

Summary

Timeline

Publications

Drugs

Indications