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

Instituto Nacional de Cancerologia de Mexico

Status and phase: Terminated; Phase 2

Conditions: Brain Metastasis

Treatments: Drug: Chloroquine; Radiation: Total brain radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01894633

CD-449-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 46 to 61 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 2 patient groups, including a placebo group

Chloroquine, radiosensitizer

Experimental group

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.

Treatment:

Radiation: Total brain radiotherapy

Drug: Chloroquine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Radiation: Total brain radiotherapy