Ipilimumab Induction in Patients With Melanoma Brain Metastases Receiving Stereotactic Radiosurgery

Inclusion Criteria

• •Patients with a histologically-confirmed diagnosis of melanoma who have imaging findings suggestive of 1 to 4 brain metastases
• •At least one lesion in the brain that is measurable, which is defined as ≥5 x 5mm (Prior craniotomy and surgical resection is allowed, as long as there is at least one remaining measurable lesion in the brain)
• •Patients must be candidates for stereotactic radiosurgery (SRS) and planning to undergo SRS
• •Patients must be candidates for ipilimumab as determined by the treating physician
• •Patients must be neurologically asymptomatic, or very minimally symptomatic, as judged by the treating physicians
• •At least 3 weeks has elapsed from any prior therapy, and the patient has recovered from side effects to ≤ grade 1 toxicities per Common Terminology Criteria (CTC) for Adverse Events
• •Age \> or = 18 years old
• •Performance status of ECOG of 0 or 1 (ECOG is the Eastern Oncology Cooperative Group Scoring system used to quantify cancer patients' general well-being and activities of daily life; scores range from 0 to 5 where 0 is perfect health and 5 is death)
• •Adequate organ and marrow function: alanine aminotransferase (ALT ) \< 2.5x's upper limit of normal (ULN) of the institutional normal reference range, aspartate aminotransferase (AST) \< 2.5x's ULN of the institutional normal reference range, Bilirubin \< 1.5x's ULN of the institutional normal reference range, Creatinine \< 2.0 milligrams per deciliter, Platelets \> 50,000 per microliter
• •Women of child-bearing potential must agree to use adequate contraception, defined as complete abstinence from intercourse with men or two methods
• •Ability to understand and the willingness to sign a written informed consent