Brain Metastasis
Conditions
Keywords
chloroquine, WBRT, survival, brain metastasis, radiotherapy, SNPs, gene coding, immunoregulatory enzyme IDO2
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.
Interventions
250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks
Sponsors
Main Line Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary endpoint: death | up to 24 months after completion of treatment | from any cause |
Other
| Measure | Time frame | Description |
|---|---|---|
| Additional Aims | up to 24 months after completion of treatment | Record the status of patient metastases (i.e. number, location, size) |
Countries
United States
Outcome results
None listed