Study of Whole-brain Irradiation With Chloroquine for Brain Metastases

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01894633

Acronym

CLQ

Enrollment

Registered

2013-07-10

Start date

2011-05-31

Completion date

2013-01-31

Last updated

2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastasis

Keywords

Prophylactic Cranial Irradiation, Metastasis, Cloroquine

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.

Interventions

DRUGChloroquine

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

RADIATIONTotal brain radiotherapy

30 Gy in 10 daily fractions from Monday to Friday

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

46 Years to 61 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
Quality of life in brain metastases	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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026