Study of Whole-brain Irradiation With Chloroquine for Brain Metastases
Information source: Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Metastasis
Intervention: Chloroquine (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Instituto Nacional de Cancerologia de Mexico Official(s) and/or principal investigator(s):
Oscar Arrieta, MD, Principal Investigator, Affiliation: Instituto Nacional de Cancerologia, Columbia
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.
Clinical Details
Official title: Phase II Randomized, Double Blind, Placebo Controlled Study of Whole-brain Irradiation With Concomitant Daily-dose Chloroquine for Brain Metastases.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Response Rate
Secondary outcome: Central Nervous System Progression Free Survival
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.
Results: The response rates (RRs) were 54% for the CLQ plus WBI arm and 55% for the control
arm (p=0. 92). The progression-free survival (PFS) rates at one year were 83. 9% (95% CI
69. 4-98. 4) for the CLQ group and 55. 1% (95% CI 33. 6-77. 6) for the placebo group. Treatment
with CLQ was independently associated with increased PFS in patients with brain metastases
(RR 0. 31, 95% CI [0. 1-0. 9], p=0. 046).The only factor that was independently associated with
increased overall survival (OS) was the presence of < 4 brain metastases (RR 1. 9, 95% CI
[1. 12-3. 3], p=0. 017). WBI was associated with improvements in cognitive and emotional
function but also with worsened nausea in both patient groups. No differences in QoL or
toxicity were found between the study arms. However, this difference was not associated with
a difference in quality of life.
Eligibility
Minimum age: 46 Years.
Maximum age: 61 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Instituto Nacional de Cancerologia, Mexico DF, DF 14080, Mexico
Additional Information
Starting date: May 2011
Last updated: July 3, 2013
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