An interventional study of Chloroquine diphosphate in Brain Metastasis, sponsored by Main Line Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-08.
Sponsored by Main Line Health · Not applicable, Interventional, and Treatment
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.
Hypothesis one: A short course of chloroquine one week prior and four weeks after initiation of WBRT is tolerable and significantly increases the median survival time of patients suffering from brain metastasis as assessed one, three, six, nine, twelve and 24 months post radiotherapy, when compared to historic controls.
Hypothesis two: The presence of one or both single-nucleotide polymorphisms (SNP)s in the gene coding for the immunoregulatory enzyme indoleamine 2,3-dioxygenase 2 (IDO2) improves the clinical outcomes of WBRT or the response to CQ co-treatment.
3.2. Specific Aims:
The specific aims of this study are:
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 20 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Main Line Health is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks.
Drug: Chloroquine diphosphate
250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks
Specific Aim
Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy
Time frame: up to 24-months after completion of treatment
Secondary endpoint: death
from any cause
Time frame: up to 24 months after completion of treatment
Additional Aims
Record the status of patient metastases (i.e. number, location, size)
Time frame: up to 24 months after completion of treatment
Additional Aims
Record KPS
Time frame: up to 24 months after completion of treatment
Additional Aims
Record genotype of IDO2
Time frame: up to 24 months after completion of treatment
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Main Line Health