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NCT01480050

Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma

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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·ClinicalTrials.gov·drugCompleted
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Study focus
Disease/Condition
Brain and Central Nervous System Tumors
Drug/Device/Intervention
temozolomide
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Location
Birmingham,Atlanta,Baltimore,Detroit,Winston-Salem,Philadelphia,Pittsburgh, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
May 31, 2012
End date
Jun 01, 2017
Enrollment
28 participants
Primary outcome

Maximum-tolerated dose of mibefradil dihydrochloride,Dose-limiting toxicity

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.

ICD-10 classifications
Malignant neoplasm: Overlapping lesion of brain and other parts of central nervous systemMalignant neoplasm: Central nervous system, unspecifiedBenign neoplasm of brain and other parts of central nervous systemMalignant neoplasm of brainSecondary malignant neoplasm of other and unspecified parts of nervous system
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT01480050
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT01480050 through Pure Global AI's free database. This Phase 1 trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and is currently Completed. The study focuses on Brain and Central Nervous System Tumors. Target enrollment is 28 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.