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Chloroquine for Treatment of Glioblastoma Multiforme

This study has been completed.
Sponsor:
Information provided by:
National Institute of Neurology and Neurosurgery, Mexico
ClinicalTrials.gov Identifier:
NCT00224978
First received: September 21, 2005
Last updated: November 17, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Glioblastoma Multiforme
 Drug: Chloroquine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Chloroquine as Adjuvant to the Treatment of Glioblastoma Multiforme, A Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Neurology and Neurosurgery, Mexico:

Primary Outcome Measures:
  • Survival after surgery

Secondary Outcome Measures:
  • End-point evaluation, survival at two years

Study Start Date: January 2005
Estimated Study Completion Date: August 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224978

Locations
Mexico
National Institute of Neurology and Neurosurgery
Mexico City, Mexico, 14269
Sponsors and Collaborators
National Institute of Neurology and Neurosurgery, Mexico
Investigators
Principal Investigator: Julio Sotelo, MD National Institute of Neurology and Neurosurgery of Mexico
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00224978     History of Changes
Other Study ID Numbers: 14/99
Study First Received: September 21, 2005
Last Updated: November 17, 2009
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Chloroquine
Chloroquine diphosphate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics

ClinicalTrials.gov processed this record on May 23, 2013