Study of Whole-brain Irradiation With Chloroquine for Brain Metastases

Phase 2TerminatedNCT01894633

Instituto Nacional de Cancerologia de Mexico73 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Brain Metastasis

Interventions

ChloroquineDRUG

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

Total brain radiotherapyRADIATION

30 Gy in 10 daily fractions from Monday to Friday

Eligibility

Sex: ALLMin age: 46 YearsMax age: 61 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto Nacional de Cancerologia

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

Overall Response Rate

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 Outcomes

Central Nervous System Progression Free Survival

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

Data from ClinicalTrials.gov

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