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

NCT ID: NCT01727531

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2013-08-31

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.

Conditions

Brain Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CQ Arm

250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks.

Group Type: EXPERIMENTAL

Chloroquine diphosphate

Intervention Type: DRUG

250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Main Line Health

OTHER

Sponsor Role: lead

Responsible Party

Albert DeNittis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Albert DeNittis, MD

Role: PRINCIPAL_INVESTIGATOR

Main Line Health

Locations

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Countries

United States

Other Identifiers

R09-2775L

Identifier Type: -

Identifier Source: org_study_id