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Adding Chloroquine to Conventional Treatment for Glioblastoma Multiforme: A Randomized, Double-Blind, Placebo-Controlled Trial

Julio Sotelo, MD; Eduardo Briceño, MD; and Miguel Angel López-González, MD
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From the National Institute of Neurology and Neurosurgery of Mexico.

ClinicalTrials.gov Identifier: NCT00224978

Acknowledgments: The authors thank Camilo Ríos, PhD, for help with statistical analysis; Roberto Medina, MD, for coding the treatment sets; and Beatriz Cano for monitoring the coded and sealed treatment sets.

Grant Support: By Consejo Nacional de Ciencia y Tecnología (CONACyT) (SALUD-2003-C01-15.)

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Julio Sotelo, MD, National Institute of Neurology and Neurosurgery of Mexico, Insurgentes Sur 3877, 14269 Mexico City, Mexico; e-mail, jsotelo@servidor.unam.mx.

Current Author Addresses: Drs. Sotelo, Briceño, and López-González: National Institute of Neurology and Neurosurgery of Mexico, Insurgentes Sur 3877, 14269 Mexico City, Mexico.

Author Contributions: Conception and design: J. Sotelo.

Analysis and interpretation of the data: J. Sotelo.

Drafting of the article: J. Sotelo.

Critical revision of the article for important intellectual content: J. Sotelo, E. Briceño.

Final approval of the article: J. Sotelo, E. Briceño, M.A. López-González.

Provision of study materials or patients: E. Briceño, M.A. López-González.

Statistical expertise: M.A. López-González.

Obtaining of funding: J. Sotelo.

Administrative, technical, or logistic support: J. Sotelo.

Collection and assembly of data: E. Briceño, M.A. López-González.

Ann Intern Med. 2006;144(5):337-343. doi:10.7326/0003-4819-144-5-200603070-00008
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The addition of chloroquine to the conventional therapeutic approach for glioblastoma multiforme may increase mid-term survival; however, this figure is higher in our study than that obtained recently with novel chemotherapeutic agents (13). The inclusion criteria and treatment of patients who participated in the current study were identical to those of the 18 patients in our preliminary open-label study of glioblastoma multiforme (6). The results of both studies were similar and support a mid-term beneficial effect of chloroquine in the treatment of this disorder. Chloroquine is not a cytotoxic substance, and a well-described, relevant antineoplastic effect does not exist. Therefore, we speculate that the mechanisms for this effect on therapy could involve either the enhancement of cytotoxicity induced by conventional treatments or the prevention of mutagenicity in neoplastic cells, which maintain their susceptibility to radiotherapy and chemotherapy by allowing them to elude the appearance of resistant cell clones.

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Figure 1.
Kaplan–Meier estimates of survival in 30 patients with glioblastoma multiforme who received chloroquine (n= 15) or placebo (n= 15) in addition to conventional therapy.

    At the end of the observation period, 6 patients from the chloroquine-treated group and 3 patients from the control group survived.

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Figure 2.
Magnetic resonance imaging scan of a patient with glioblastoma multiforme treated with chloroquine in addition to surgery, chemotherapy, and radiotherapy.Top.Bottom.

A large mass is shown on the left hemisphere before treatment. Forty-four months after the beginning of treatment, no evidence of tumor regrowth is seen. At this time, the patient's Karnofsky performance score was 100 (asymptomatic).

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Summary for Patients

Adding Chloroquine to Conventional Chemotherapy and Radiotherapy for Glioblastoma Multiforme

The summary below is from the full report titled “Adding Chloroquine to Conventional Treatment for Glioblastoma Multiforme. A Randomized, Double-Blind, Placebo-Controlled Trial.” It is in the 7 March 2006 issue of Annals of Internal Medicine (volume 144, pages 337-343). The authors are J. Sotelo, E. Briceño, and M.A. López-González.


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