Clinical trial

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

Name

CD-449-08

Description

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.

Trial arms

Trial start

2011-05-01

Estimated PCD

2012-04-01

Trial end

2013-01-01

Status

Terminated

Phase

Early phase I

Treatment

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

Arms:

Chloroquine, radiosensitizer

Other names:

Aralen

Total brain radiotherapy

30 Gy in 10 daily fractions from Monday to Friday

Arms:

Chloroquine, radiosensitizer, Placebo

Size

Primary endpoint

Overall Response Rate

Every third month after randomization until 24 months follow-up. Measured by brain MRI

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 73, 'type': 'ACTUAL'}}

Updated at

2024-01-24

1 organization

1 product

1 indication

Organization

Instituto Nacional de Cancerologia de Mexico

Product

Chloroquine

Indication

Metastatic Brain Tumor