32
Participants
Start Date
July 31, 2005
Primary Completion Date
October 31, 2009
Study Completion Date
December 31, 2012
sargramostim
All patients will receive GM-CSF at a dose of 250 mcg subcutaneously on Mondays, Wednesdays and Fridays every week. No dose escalation or de-escalations will be made to GM-CSF.
lenalidomide
Lenalidomide will be administered at 25 mg/day orally on days 1-21 of a 28-day cycle. Initially 6 patients will be entered at the 25 mg/day level. If 0 or 1 patients have a dose limiting toxicity, then the 25 mg lenalidomide + GM-CSF 250 mcg subcutaneously on Mondays, Wednesdays and Fridays every week will be accepted as the phase II dose.
laboratory biomarker analysis
Prior to the initiation of each cycle of therapy for the first 3 cycles, and at discontinuation from study blood will be collected for assessments of a prostate cancer specific immune response.
Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center, Cleveland
National Cancer Institute (NCI)
NIH
Robert Dreicer MD
OTHER