Clinical Trial Finder

Inclusion Criteria:

• - All patients with histologic proof of malignant melanoma.

Histologic confirmation may be from the primary tumor site, or from another metastatic site (systemic lymph node, etc). Cytology-alone is not an acceptable method of diagnosis.

• - Greater than 3 presumed melanoma brain metastases on contrast-enhanced brain MRI scan obtained no greater than 4 weeks prior to study registration.

• - Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.

• - Patients must have Karnofsky performance status (KPS) >= 70.

• - Patients must be eligible to have all lesions treated as determined by the study radiation oncologist.

• - Creatinine clearance > 30 ml/min.

• - Platelets > 50,000.

• - Patients should have normal coagulation (international normalized ratio [INR] < 1.3) and be able to withhold anticoagulation/antiplatelet medications a minimum of 24 hours prior to radiosurgery treatment (or until INR normalizes), on the day of treatment and 24 hours after radiosurgery treatment has concluded.

• - Patients can be undergoing concurrent systemic therapy, such as temozolomide, at the discretion of their treating oncologist.

Exclusion Criteria:

• - Patients are excluded if they have been treated with whole brain radiotherapy within the prior 3 months.

• - Patients are excluded if they have a history of metastatic cancer in addition to melanoma or a history of uncontrolled non-metastatic cancer.

Patients with localized squamous cell carcinoma and/or basal cell carcinoma are not excluded.

• - Patients are excluded if there is radiographic or cerebrospinal fluid (CSF) evidence of leptomeningeal disease.

• - Female patients of childbearing age are excluded if they are pregnant as determined with a serum beta HCG no greater than 14 days prior to study registration, or breast-feeding.

(The exclusion is made because gadolinium may be teratogenic in pregnancy)

• - Patients are excluded if there is any history of gadolinium allergy.

- Patients are excluded if they are unable to obtain a magnetic resonance imaging (MRI) scan for any other reason

PRIMARY OBJECTIVES:

• I. To determine local control of brain metastases at 4 months after initial treatment with stereotactic radiosurgery (SRS) in patients with > 3 melanoma brain metastases (MBM).

• II. To determine cognitive decline at 4 months defined as a significant decline (>= 5 point decrease from baseline based on the reliable change index) in the Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall after initial treatment with SRS versus whole brain radiation therapy (WBRT) in patients with > 3 MBMs.

SECONDARY OBJECTIVES:

• I. To determine local tumor control and distal tumor control in the brain at 1, 4, 6, 9 and 12 months post-treatment.

• II. To determine overall survival in treated patients.

• III. To assess the pattern of neurocognitive change in memory at 1, 4, 6, 9, and 12 months post-treatment as well as executive function, attention, processing speed and upper extremity fine motor dexterity.

• IV. To evaluate composite neurocognitive function scores in treated patients.

• V. To assess the pre-treatment factors of age, Karnofsky performance scale (KPS), extra-cranial disease, BRAF-V600E mutation status in the predictive determination of local and distal control and neurocognitive outcome in each treatment arm.

• VI. To assess the correlation between number of lesions and total volume of intracranial disease and neurocognitive outcome in each treatment arm.

• VII. To document post-treatment adverse side effects in treated patients.

• VIII. Evaluate the time to initiation of systemic therapy from completion of radiation treatment.

• IX. Evaluate the duration/number of cycles of systemic chemotherapy given following radiation treatment.

CORRELATIVE STUDIES:

• I. To determine if apolipoprotein E (Apo E) (i.e., Apo E2, Apo E3, and Apo E4) genotyping may prove to be a predictor of radiation induced neurocognitive decline (or neuro-protection).

• II. To determine if inflammatory markers (i.e., IL-1, IL-6, and TNF-alpha) may prove to be predictors of radiation induced neurocognitive decline.

• III. To determine if hormone and growth factors (i.e., glucocorticoids [e.g., cortisol], gonadal steroids [e.g., estradiol, testosterone, progesterone], growth hormone, human chorionic gonadotropin (hCG), insulin-like growth factor-1 [IGF-1], and neuronal growth factor [NGF]) may prove to be a predictor of radiation induced neurocognitive decline.

• IV. To assess whether baseline and post-radiation fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scans can predict for neurocognitive decline.

OUTLINE: Patients undergo SRS on day 1. After completion of study treatment, patients are followed up for 12 months.

Arms

Experimental: Treatment (SRS)

Patients undergo SRS on day 1.

Interventions

Other: - Quality-of-Life Assessment

Ancillary studies

Other: - Questionnaire Administration

Ancillary studies

Radiation: - Stereotactic Radiosurgery

Undergo SRS