Chloroquine for Treatment of Glioblastoma Multiforme - Full Text View

Sponsored by:	National Institute of Neurology and Neurosurgery, Mexico
Information provided by:	National Institute of Neurology and Neurosurgery, Mexico
ClinicalTrials.gov Identifier:	NCT00224978

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 we 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 III

Drug Information available for: Chloroquine Chloroquine diphosphate Chloroquine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title:	Chloroquine as Adjuvant to the Treatment of Glioblastoma Multiforme, A Randomized Trial

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 of Results:

Briceno E, Reyes S, Sotelo J. Therapy of glioblastoma multiforme improved by the antimutagenic chloroquine. Neurosurg Focus. 2003 Feb 15;14(2):e3.

Sotelo J, Briceno E, Lopez-Gonzalez MA. Adding chloroquine to conventional treatment for glioblastoma multiforme: a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2006 Mar 7;144(5):337-43. Summary for patients in: Ann Intern Med. 2006 Mar 7;144(5):I31.

Study ID Numbers:	14/99
Study First Received:	September 21, 2005
Last Updated:	May 8, 2006
ClinicalTrials.gov Identifier:	NCT00224978
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Study placed in the following topic categories:

Neuroectodermal Tumors
Glioblastoma
Glioblastoma multiforme
Astrocytoma
Chloroquine diphosphate

Neoplasms, Germ Cell and Embryonal
Chloroquine
Neuroepithelioma
Glioma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Neoplasms by Histologic Type
Filaricides
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Anthelmintics
Pharmacologic Actions
Antimalarials
Neoplasms
Antiparasitic Agents

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Amebicides
Neoplasms, Neuroepithelial
Antirheumatic Agents
Central Nervous System Agents
Antinematodal Agents

ClinicalTrials.gov processed this record on January 16, 2009