Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma
NCT01480050 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2019-05-22
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.
Conditions
Interventions
- DRUG
-
standard of care drug
- OTHER
-
3'-deoxy-3'-[18F]fluorothymidine
tracer used for FLT PET CT
- OTHER
-
pharmacological study
- DRUG
-
Mibefradil
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Cavion, Inc.
collaborator INDUSTRY -
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
lead OTHER
Principal Investigators
-
Matthias Holdhoff, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-31
- Primary Completion
- 2015-08-31
- Completion
- 2017-06-01
Countries
- United States
Study Locations
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