NCT01644591 · Phase 2 · ACTIVE NOT RECRUITING
Stereotactic Radiosurgery in Treating Patients With Greater Than 3 Melanoma Brain Metastases
This trial tests stereotactic radiosurgery — a precise, high-dose radiation technique aimed at individual tumors — in patients whose melanoma has spread to more than three spots in the brain. Researchers are measuring how well it works and how it affects quality of life. This is a Phase 2 trial, meaning it is testing effectiveness and safety but the approach is not yet proven or approved for this specific situation.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-05