Study of Whole-brain Irradiation With Chloroquine for Brain Metastases

Brain Metastasis Clinical Trial

— CLQ  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01894633
• Other study ID #: CD-449-08
• Status: Terminated
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2024
• Source: Instituto Nacional de Cancerologia de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: January 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 46 Years to 61 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastasis
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Chloroquine
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

Radiation:
• Total brain radiotherapy
30 Gy in 10 daily fractions from Monday to Friday

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cancerologia	Mexico DF	DF

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life in brain metastases	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	The quality of life questionnaires were completed 1 day before radiotherapy began and 1 month later.
Primary	Overall Response Rate	Corresponding Complete plus Partial Response according with RECIST 1.1 Criteria	Every third month after randomization until 24 months follow-up. Measured by brain MRI
Secondary	Central Nervous System Progression Free Survival	Clinical o radiological brain progression or death. Radiological Progression is measured by RECIST 1.1 Criteria	From time to progression to 24 months follow up