Study of Whole-brain Irradiation With Chloroquine for Brain Metastases

Phase 2

Terminated

• Conditions: Brain Metastasis
• Interventions: Drug: Chloroquine; Radiation: Total brain radiotherapy

• Registration Number: NCT01894633
• Lead Sponsor: Instituto Nacional de Cancerologia de Mexico

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-04
• Study Completion: 2013-01
• Study First Submitted: 2013-06-29
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chloroquine, radiosensitizer	Chloroquine	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.
Chloroquine, radiosensitizer	Total brain radiotherapy	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.
Placebo	Total brain radiotherapy	30 Gy of whole-brain radiotherapy in 10 daily fractions and an oral matching placebo for 28 days

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	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

Secondary Outcome Measures

Name	Time	Method
Central Nervous System Progression Free Survival	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

Trial Locations

Locations (1)

Instituto Nacional de Cancerologia; 🇲🇽 Mexico DF, DF, Mexico