Back to resultsIDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine (CQ) in Brain Metastasis Radiotherapy
Primary Purpose
Brain Metastasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chloroquine diphosphate
Sponsored by
About this trial
This is an interventional treatment trial for Brain Metastasis focused on measuring chloroquine, WBRT, survival, brain metastasis, radiotherapy, SNPs, gene coding, immunoregulatory enzyme IDO2
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
Sites / Locations
- Lankenau Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CQ Arm
Arm Description
250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks.
Outcomes
Primary Outcome Measures
Specific Aim
Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy
Secondary Outcome Measures
Secondary endpoint: death
from any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01727531
Brief Title
IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine (CQ) in Brain Metastasis Radiotherapy
Official Title
IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine in Brain Metastasis Radiotherapy.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Main Line Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy.
Record the status of patient metastases (i.e. number, location, size)
Determine patients' KPS values.
Record the incidence and causes of mortality of patients.
Determine the genotype of IDO2 for each patient.
Following data analysis, test the validity of the two hypotheses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastasis
Keywords
chloroquine, WBRT, survival, brain metastasis, radiotherapy, SNPs, gene coding, immunoregulatory enzyme IDO2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CQ Arm
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Chloroquine diphosphate
Intervention Description
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 Measure Information:
Title
Specific Aim
Description
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 Outcome Measure Information:
Title
Secondary endpoint: death
Description
from any cause
Time Frame
up to 24 months after completion of treatment
Other Pre-specified Outcome Measures:
Title
Additional Aims
Description
Record the status of patient metastases (i.e. number, location, size)
Time Frame
up to 24 months after completion of treatment
Title
Additional Aims
Description
Record KPS
Time Frame
up to 24 months after completion of treatment
Title
Additional Aims
Description
Record genotype of IDO2
Time Frame
up to 24 months after completion of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert DeNittis, MD
Organizational Affiliation
Main Line Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
12. IPD Sharing Statement
Learn more about this trial
IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine (CQ) in Brain Metastasis Radiotherapy
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