RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.
OBJECTIVES: * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day
doses up to 400 mg/day
SOC care surgery
Cleveland Clinic
Cleveland, Ohio, United States
Proportion of Patients P0 at Surgery
Pathologic Complete Response is defined as complete eradication of tumor.
Time frame: 8 weeks
Proportion of Patients With Negative Surgical Margins
Presence or Absence of prostate cancer tissue at the sites of surgical resection. This is done by reviewing the entire specimen resected at the time or Radical Prostatectomy.
Time frame: 8 Weeks
Prostate-specific Antigen Response
Number of subjects that achieved a PSA decline while on therapy. Any PSA decline while on treatment, compared with baseline PSA prior to study entry.
Time frame: 8 weeks
Time to Clinical Progression
Time to progression. WIth a median follow up of 32 months (12-51 months), 5 of 26 patients developed biochemical failure.
Time frame: 32 months
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post radical prostatectomy