Phase I/II Study of Lenalidomide (RevlimidTM ) and GM-CSF in Androgen Independent Prostate Cancer
- Establish the safety of a predetermined target dose or, if the target dose is not
tolerable, find the maximum tolerated dose of lenalidomide when administered in
combination with sargramostim in patients with androgen-independent prostate cancer.
- Evaluate the preliminary efficacy of this regimen to ascertain whether additional study
of lenalidomide is warranted in patients with androgen-independent prostate cancer.
- Evaluate the safety of this regimen in these patients.
- Describe the effects of this regimen on serum cytokines (e.g., TNF-α, bFGF, sIL2R,
IL-8, and IL-12) and on serum VEGF levels.
- Assess the co-stimulatory effects of this regimen on CD4+, CD8+, CD83, and CD86 cells.
OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II
Patients receive oral lenalidomide on days 1-21 and sargramostim subcutaneously on days 1,
3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
Blood samples are collected periodically for correlative biomarker and immunological
After completion of study therapy, patients are followed up at 30 days and then every 3
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With a PSA Response
Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.
reevaluated for response every eight weeks
Robert Dreicer, MD, FACP
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|