Study: Melanoma Drug Promising for Brain Mets (CME/CE)
last year for use in patients with metastatic melanoma after it was shown to extend overall survival in this population.
Yet no trials had specifically assessed its effects in melanoma patients whose tumors had spread to the brain.
Current therapies for metastatic melanoma in the brain include surgery, stereotactic radiosurgery, and whole-brain radiation.
Concomitant steroids are also thought to improve symptoms, and temozolomide (Temodar) is the most widely used systemic treatment in this group.
Preliminary evidence has suggested that ipilimumab, along with vemurafenib (Zelboraf) and another investigational BRAF inhibitor, GSK118436, have activity against melanoma brain metastases.
So Margolin and colleagues enrolled 72 patients with melanoma brain metastases in a phase II safety and efficacy trial at 10 U.S.
centers, and divided them into two cohorts: an asymptomatic group not currently taking corticosteroids (51 patients) and 21 symptomatic patients taking the anti-inflammatory agents.
Patients had four intravenous doses of ipilimumab at 10 mg/kg, one every 3 weeks for 12 weeks -- a higher dose and more frequent schedule than is currently licensed.
The primary endpoint was the proportion of patients with disease control, defined as complete response, partial response, or stable disease.
By study end, nine of the asymptomatic patients (18%) had disease control, as did one symptomatic patient (5%), based on modified WHO criteria.
Only 15 of the original 51 asymptomatic patients completed induction and 11 entered the maintenance phase of the trial; in the symptomatic group, five of 21 patients completed induction and two entered the maintenance phase.