IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine (CQ) in Brain Metastasis Radiotherapy
1 other identifier
interventional
20
1 country
1
Brief Summary
This research is being done to determine if a short course of Chloroquine (five weeks) before, during and after whole brain radiation therapy (WBRT) will improve the overall survival of subjects being treated for brain metastases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2008
Longer than P75 for not_applicable
1 active site
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
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 7, 2012
CompletedFirst Posted
Study publicly available on registry
November 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedApril 8, 2015
April 1, 2015
4.7 years
November 7, 2012
April 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Specific Aim
Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy
up to 24-months after completion of treatment
Secondary Outcomes (1)
Secondary endpoint: death
up to 24 months after completion of treatment
Other Outcomes (3)
Additional Aims
up to 24 months after completion of treatment
Additional Aims
up to 24 months after completion of treatment
Additional Aims
up to 24 months after completion of treatment
Study Arms (1)
CQ Arm
EXPERIMENTAL250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks.
Interventions
250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks
Eligibility Criteria
You may qualify if:
- Patients with histologically confirmed primary solid malignancy
- Patients with single or multiple brain metastases
- Patients with metastasis diameter \< 5 cm
- Age \> 18
- Clearance from the patient's physician that treatment with chloroquine should not pose a problem to the patient
You may not qualify if:
- Patients with a history of hypotension, cardiomyopathy, epilepsy, seizures
- Patients with impaired renal function
- Patients with psoriasis, porphyria
- Patients with known hypersensitivity to 4-aminoquinoline compounds
- Pregnancy, nursing
- Prior radiotherapy
- During the chloroquine treatment, patients complaining from visual or auditory disturbances, and patients suffering from acute gastrointestinal problems i.e. Anorexia, nausea, vomiting, diarrhea, abdominal cramps
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Main Line Healthlead
Study Sites (1)
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albert DeNittis, MD
Main Line Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 7, 2012
First Posted
November 16, 2012
Study Start
December 1, 2008
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
April 8, 2015
Record last verified: 2015-04