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
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Lankenau Medical Center, Wynnewood, Pennsylvania 19096, United States
Additional Information
Starting date: December 2008
Last updated: April 7, 2015
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