Study of Whole-brain Irradiation With Chloroquine for Brain Metastases (CLQ)

January 23, 2024 updated by: Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • DF
      • Mexico DF, DF, Mexico, 14080
        • Instituto Nacional de Cancerologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 61 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 to 80 years of age
  • At leat one brain metastasis MRI
  • KPS 70 or more
  • RTOG-RPA I or II
  • Basic Laboratory requirements

Exclusion Criteria:

  • Candidates for radiosurgery, neurosurgery
  • Patients treated with radiotherapy before entered to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chloroquine, radiosensitizer
The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the CLQ plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days.
Drug: Chloroquine
The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the Chloroquine plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days
Other Names:
  • Aralen
Radiation: Total brain radiotherapy
30 Gy in 10 daily fractions from Monday to Friday
Placebo Comparator: Placebo
30 Gy of whole-brain radiotherapy in 10 daily fractions and an oral matching placebo for 28 days
Radiation: Total brain radiotherapy
30 Gy in 10 daily fractions from Monday to Friday

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Every third month after randomization until 24 months follow-up. Measured by brain MRI
Corresponding Complete plus Partial Response according with RECIST 1.1 Criteria
Every third month after randomization until 24 months follow-up. Measured by brain MRI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Nervous System Progression Free Survival
Time Frame: From time to progression to 24 months follow up
Clinical o radiological brain progression or death. Radiological Progression is measured by RECIST 1.1 Criteria
From time to progression to 24 months follow up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life in brain metastases
Time Frame: The quality of life questionnaires were completed 1 day before radiotherapy began and 1 month later.
The 30-item EORTC Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) version 3.0 (Mexican version) was used in this trial. The EORTC QLQ-C30 v3 consisted of five multi-item functional scales, three symptom scales, a global health status/QoL scale, and six single items
The quality of life questionnaires were completed 1 day before radiotherapy began and 1 month later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Investigators

  • Principal Investigator: Oscar Arrieta, MD, Instituto Nacional de Cancerologia, Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 29, 2013

First Submitted That Met QC Criteria

July 3, 2013

First Posted (Estimated)

July 10, 2013

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-449-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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