Chloroquine for Treatment of Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Chloroquine is a strong lysosomotropic and DNA-intercalating agent in experimental studies (Neurosurgical Focus 14(2): February, 2003) and an open-label clinical trial the investigators have demonstrated a strong adjuvant effect of chloroquine on the therapy of malignant gliomas. This study will assess in a randomized, placebo-controlled, double-blind study the effects of chloroquine as adjuvant to the conventional therapy of Glioblastoma Multiforme.

• Phase: Phase 3

Details

• Lead Sponsor: National Institute of Neurology and Neurosurgery, Mexico
• Treatments: Chloroquine; Chloroquine diphosphate

Criteria

Inclusion Criteria:

• Tumor restricted to one hemisphere of the brain

• Karnofsky scale >7

• Histologically confirmed GBM in first or second recurrence or relapse

• Adequate hematologic, hepatic and renal function

• Karnofsky performance status score ≥ 70%

• Life expectancy ≥ 16 weeks

Exclusion Criteria:

• Gastrointestinal dysfunction

• Compromised cardiac function

• Concurrent severe and /or uncontrolled medical conditions