Stereotactic Radiosurgery in Treating Patients With Greater Than 3 Melanoma Brain Metastases

Running, not enrolling · Phase 2

Conditions studied: Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Melanoma, Pathologic Stage IV Cutaneous Melanoma AJCC v8

In brief

This phase II trial studies how well stereotactic radiosurgery works in treating patients with melanoma that has spread to more than 3 places in the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

Key facts

Study ID

NCT01644591

Run by

M.D. Anderson Cancer Center

People needed

49

Starts

2012-08-02

Expected to finish

2026-08-31

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 may not qualify 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

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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