NCT00224978

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
Last Updated

November 18, 2009

Status Verified

November 1, 2009

First QC Date

September 21, 2005

Last Update Submit

November 17, 2009

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

  • Survival after surgery

Secondary Outcomes (1)

  • End-point evaluation, survival at two years

Interventions

ChloroquineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Gastrointestinal dysfunction
  • Compromised cardiac function
  • Concurrent severe and /or uncontrolled medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurology and Neurosurgery

Mexico City, 14269, Mexico

Location

Related Publications (2)

  • Briceno E, Reyes S, Sotelo J. Therapy of glioblastoma multiforme improved by the antimutagenic chloroquine. Neurosurg Focus. 2003 Feb 15;14(2):e3. doi: 10.3171/foc.2003.14.2.4.

    PMID: 15727424RESULT

  • 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. doi: 10.7326/0003-4819-144-5-200603070-00008.

    PMID: 16520474RESULT

MeSH Terms

Conditions

Glioblastoma

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Julio Sotelo, MD

    National Institute of Neurology and Neurosurgery of Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 23, 2005

Study Start

January 1, 2005

Study Completion

August 1, 2005

Last Updated

November 18, 2009

Record last verified: 2009-11

Locations

ME(1)