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

Not Applicable

Completed

• Conditions: Brain Metastasis
• Interventions: Drug: Chloroquine diphosphate

• Registration Number: NCT01727531
• Lead Sponsor: Main Line Health

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.

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-16
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CQ Arm	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.

Primary Outcome Measures

Name	Time	Method
Specific Aim	up to 24-months after completion of treatment	Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint: death	up to 24 months after completion of treatment	from any cause

Trial Locations

Locations (1)

Lankenau Medical Center; 🇺🇸 Wynnewood, Pennsylvania, United States