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IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine (CQ) in Brain Metastasis Radiotherapy

Information source: Main Line Health
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Metastasis

Intervention: Chloroquine diphosphate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Main Line Health

Official(s) and/or principal investigator(s):
Albert DeNittis, MD, Principal Investigator, Affiliation: Main Line Health


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.

Clinical Details

Official title: IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine in Brain Metastasis Radiotherapy.

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Specific Aim

Secondary outcome: Secondary endpoint: death

Detailed description: 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: 1. Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy. 2. Record the status of patient metastases (i. e. number, location, size) 3. Determine patients' KPS values. 4. Record the incidence and causes of mortality of patients. 5. Determine the genotype of IDO2 for each patient. 6. Following data analysis, test the validity of the two hypotheses.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- 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 Exclusion Criteria:

- 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

Locations and Contacts

Lankenau Medical Center, Wynnewood, Pennsylvania 19096, United States
Additional Information

Starting date: December 2008
Last updated: April 7, 2015

Page last updated: August 20, 2015

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