Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Study of Mibefradil Dihydrochloride in Patients With Recurrent High-Grade Glioma Receiving Temozolomide

Basic Trial Information

Trial Description

Purpose:

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.

This phase I trial is studying the best dose of mibefradil dihydrochloride when given together with temozolomide in treating patients with glioma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Recurrent or progressive disease after front-line radiation therapy and temozolomide
• Measurable disease
• At least 3 months since radiation therapy or temozolomide
• More than 30 days since any other glioma treatment
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive mibefradil dihydrochloride by mouth four times a day on days 1-7 (1-8 of the first course) and temozolomide by mouth on days 8-12 (9-13 of the first course). Courses may repeat every 4 weeks for as long as benefit is shown.

After finishing treatment, patients will be evaluated every 2 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Adult Brain Tumor Consortium

Matthias Holdhoff, MD, Principal investigator		Ph: 410-287-0337

U.S.A.
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu

Registry Information
Official Title		A Phase I Open Label Safety Study to Evaluate the Pharmacokinetic Profile and Tolerance of Mibefradil Dose Finding in Subjects with Recurrent High-Grade Glioma Undergoing Standard, Repeated Temozolomide Treatment
Trial Start Date		2012-04-18
Trial Completion Date		2013-01-01 (estimated)
Registered in ClinicalTrials.gov		NCT01480050
Date Submitted to PDQ		2011-11-07
Information Last Verified		2012-06-25
NCI Grant/Contract Number		CA-137443

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