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

I

Instituto Nacional de Cancerologia de Mexico

Status and phase

Terminated
Phase 2

Conditions

Brain Metastasis

Treatments

Radiation: Total brain radiotherapy
Drug: Chloroquine

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

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:
Drug: Chloroquine
Radiation: Total brain radiotherapy
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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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