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Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma - Trial NCT01480050

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.

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NCT01480050
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT01480050
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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

Study Focus

temozolomide

Interventional

drug

Sponsor & Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Birmingham,Atlanta,Baltimore,Detroit,Winston-Salem,Philadelphia,Pittsburgh, United States of America

Timeline & Enrollment

Phase 1

May 31, 2012

Jun 01, 2017

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 system
Malignant neoplasm: Central nervous system, unspecified
Benign neoplasm of brain and other parts of central nervous system
Malignant neoplasm of brain
Secondary malignant neoplasm of other and unspecified parts of nervous system

Data Source

ClinicalTrials.gov

NCT01480050

Non-Device Trial