Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

October 31, 2009

Study Completion Date

December 31, 2012

Conditions
Prostate Cancer
Interventions
BIOLOGICAL

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.

DRUG

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.

OTHER

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.

Trial Locations (1)

44195

Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Robert Dreicer MD

OTHER

NCT00939510 - Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer | Biotech Hunter | Biotech Hunter