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

Primary Purpose

Brain Metastasis

Status
Terminated
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Chloroquine
Total brain radiotherapy
Sponsored by
Instituto Nacional de Cancerologia de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastasis focused on measuring Prophylactic Cranial Irradiation, Metastasis, Cloroquine

Eligibility Criteria

46 Years - 61 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Nacional de Cancerologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chloroquine, radiosensitizer

Placebo

Arm Description

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.

30 Gy of whole-brain radiotherapy in 10 daily fractions and an oral matching placebo for 28 days

Outcomes

Primary Outcome Measures

Overall Response Rate
Corresponding Complete plus Partial Response according with RECIST 1.1 Criteria

Secondary Outcome Measures

Central Nervous System Progression Free Survival
Clinical o radiological brain progression or death. Radiological Progression is measured by RECIST 1.1 Criteria

Full Information

First Posted
June 29, 2013
Last Updated
March 2, 2017
Sponsor
Instituto Nacional de Cancerologia de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01894633
Brief Title
Study of Whole-brain Irradiation With Chloroquine for Brain Metastases
Acronym
CLQ
Official Title
Phase II Randomized, Double Blind, Placebo Controlled Study of Whole-brain Irradiation With Concomitant Daily-dose Chloroquine for Brain Metastases.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
terminated
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cancerologia de Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastasis
Keywords
Prophylactic Cranial Irradiation, Metastasis, Cloroquine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chloroquine, radiosensitizer
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
30 Gy of whole-brain radiotherapy in 10 daily fractions and an oral matching placebo for 28 days
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Other Intervention Name(s)
Aralen
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Total brain radiotherapy
Intervention Description
30 Gy in 10 daily fractions from Monday to Friday
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
Corresponding Complete plus Partial Response according with RECIST 1.1 Criteria
Time Frame
Every third month after randomization until 24 months follow-up. Measured by brain MRI
Secondary Outcome Measure Information:
Title
Central Nervous System Progression Free Survival
Description
Clinical o radiological brain progression or death. Radiological Progression is measured by RECIST 1.1 Criteria
Time Frame
From time to progression to 24 months follow up
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
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
Time Frame
The quality of life questionnaires were completed 1 day before radiotherapy began and 1 month later.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
46 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Arrieta, MD
Organizational Affiliation
Instituto Nacional de Cancerologia, Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Cancerologia
City
Mexico DF
State/Province
DF
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Study of Whole-brain Irradiation With Chloroquine for Brain Metastases

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