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

April 7, 2015 updated by: Albert DeNittis, Main Line Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specific Aim
Time Frame: 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
up to 24-months after completion of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary endpoint: death
Time Frame: up to 24 months after completion of treatment
from any cause
up to 24 months after completion of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Aims
Time Frame: up to 24 months after completion of treatment
Record the status of patient metastases (i.e. number, location, size)
up to 24 months after completion of treatment
Additional Aims
Time Frame: up to 24 months after completion of treatment
Record KPS
up to 24 months after completion of treatment
Additional Aims
Time Frame: up to 24 months after completion of treatment
Record genotype of IDO2
up to 24 months after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Main Line Health

Investigators

  • Principal Investigator: Albert DeNittis, MD, Main Line Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 7, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (Estimate)

November 16, 2012

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R09-2775L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Metastasis

Clinical Trials on Chloroquine diphosphate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe