DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Study of Whole-brain Irradiation With Chloroquine for Brain Metastases

Information source: Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Metastasis

Intervention: Chloroquine (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Instituto Nacional de Cancerologia de Mexico

Official(s) and/or principal investigator(s):
Oscar Arrieta, MD, Principal Investigator, Affiliation: Instituto Nacional de Cancerologia, Columbia


Background and purposes: Chloroquine (CLQ), an antimalarial drug, has a lysosomatrophic effect associate with increase the sensibility of Radiation through leakage of hidroliticenzimes, increase of apoptosis, autophagy mediated by lysosomalhidrolases and increase of oxidative stress "in vitro". In this phase II study we evaluated the efficacy and safety as radiosensitizing of the Chloroquine plus concomitant 30 Gray (Gy) of Whole-brain irradiation (WBI)in patients with brain metastases (BM) from solid tumors.

Clinical Details

Official title: Phase II Randomized, Double Blind, Placebo Controlled Study of Whole-brain Irradiation With Concomitant Daily-dose Chloroquine for Brain Metastases.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Response Rate

Secondary outcome: Central Nervous System Progression Free Survival

Detailed description: Seventy-three eligible patients were randomized. Thirty-nine patients received WBI (30 Gy in 10 fractions over 2 weeks) concomitant with 150 mg of CLQ for 4 weeks (the CLQ group). Thirty-four patients received the same schedule of WBI concomitant with a placebo for 4 weeks (the control arm). All the patients were evaluated for quality of life (QoL) using the EORTC QLQ-C30 questionnaire (Mexican version) before beginning radiotherapy and one month later. Results: The response rates (RRs) were 54% for the CLQ plus WBI arm and 55% for the control arm (p=0. 92). The progression-free survival (PFS) rates at one year were 83. 9% (95% CI 69. 4-98. 4) for the CLQ group and 55. 1% (95% CI 33. 6-77. 6) for the placebo group. Treatment with CLQ was independently associated with increased PFS in patients with brain metastases (RR 0. 31, 95% CI [0. 1-0. 9], p=0. 046).The only factor that was independently associated with increased overall survival (OS) was the presence of < 4 brain metastases (RR 1. 9, 95% CI [1. 12-3. 3], p=0. 017). WBI was associated with improvements in cognitive and emotional function but also with worsened nausea in both patient groups. No differences in QoL or toxicity were found between the study arms. However, this difference was not associated with a difference in quality of life.


Minimum age: 46 Years. Maximum age: 61 Years. Gender(s): Both.


Inclusion Criteria:

- 18 to 80 years of age

- At leat one brain metastasis MRI

- KPS 70 or more


- Basic Laboratory requirements

Exclusion Criteria:

- Candidates for radiosurgery, neurosurgery

- Patients treated with radiotherapy before entered to the study

Locations and Contacts

Instituto Nacional de Cancerologia, Mexico DF, DF 14080, Mexico
Additional Information

Starting date: May 2011
Last updated: July 3, 2013

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017