NCT01894633

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

June 29, 2013

Last Update Submit

January 23, 2024

Conditions

Brain Metastasis

Keywords

Prophylactic Cranial IrradiationMetastasisCloroquine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Central Nervous System Progression Free Survival

    From time to progression to 24 months follow up

Other Outcomes (1)

  • Quality of life in brain metastases

    The quality of life questionnaires were completed 1 day before radiotherapy began and 1 month later.

Study Arms (2)

Chloroquine, radiosensitizer

EXPERIMENTAL

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.

Drug: ChloroquineRadiation: Total brain radiotherapy

Placebo

PLACEBO COMPARATOR

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

Radiation: Total brain radiotherapy

Interventions

ChloroquineDRUG

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

Also known as: Aralen
Chloroquine, radiosensitizer
Total brain radiotherapyRADIATION

30 Gy in 10 daily fractions from Monday to Friday

Chloroquine, radiosensitizerPlacebo

Eligibility Criteria

Age46 Years - 61 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 80 years of age
  • At leat one brain metastasis MRI
  • KPS 70 or more
  • RTOG-RPA I or II
  • Basic Laboratory requirements

You may not qualify if:

  • Candidates for radiosurgery, neurosurgery
  • Patients treated with radiotherapy before entered to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Brain NeoplasmsNeoplasm Metastasis

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Oscar Arrieta, MD

    Instituto Nacional de Cancerologia, Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2013

First Posted

July 10, 2013

Study Start

May 1, 2011

Primary Completion

April 1, 2012

Study Completion

January 1, 2013

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations

ME(1)