Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy
- Evaluate the impact of neoadjuvant sargramostim (GM-CSF) and thalidomide on pathologic
response (histologic P0, margin positivity, capsular penetration), prostate-specific
antigen (PSA) response, and other investigational endpoints in patients with high-risk
prostate cancer undergoing prostatectomy.
- Determine the safety and feasibility of GM-CSF and thalidomide.
OUTLINE: This is an open-label study.
Patients receive sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5 and oral
thalidomide on days 1-5 or 1-7 in weeks 1-4. Treatment repeats every 4 weeks for 2 courses
in the absence of unacceptable toxicity.
Patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy at week 8 or 9.
PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Proportion of patients P0 at surgery
Robert Dreicer, MD, FACP
Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|