Study of Whole-brain Irradiation With Chloroquine for Brain Metastases

NCT ID: NCT01894633

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Chloroquine, radiosensitizer

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.

Group Type EXPERIMENTAL

Chloroquine

Intervention Type DRUG

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

Total brain radiotherapy

Intervention Type RADIATION

30 Gy in 10 daily fractions from Monday to Friday

Placebo

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

Group Type PLACEBO_COMPARATOR

Total brain radiotherapy

Intervention Type RADIATION

30 Gy in 10 daily fractions from Monday to Friday

Interventions

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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

Intervention Type DRUG

Total brain radiotherapy

30 Gy in 10 daily fractions from Monday to Friday

Intervention Type RADIATION

Other Intervention Names

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Aralen

Eligibility Criteria

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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
Minimum Eligible Age

46 Years

Maximum Eligible Age

61 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Cancerologia de Mexico

OTHER

Sponsor Role lead

Responsible Party

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Oscar Gerardo Arrieta Rodríguez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oscar Arrieta, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancerologia, Columbia

Locations

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Instituto Nacional de Cancerologia

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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CD-449-08

Identifier Type: -

Identifier Source: org_study_id

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