GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer
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.
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy|
- Proportion of patients P0 at surgery [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Proportion of patients with negative surgical margins [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
- Prostate-specific antigen response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Time to clinical progression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Experimental: GM-CSF Injections and Oral Thalidomide
taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.
administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day
Other Name: GM-CSFDrug: thalidomide
doses up to 400 mg/day
Other Name: THALOMIDProcedure: conventional surgery
SOC care surgeryProcedure: neoadjuvant therapy
post radical 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400517
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Robert Dreicer, MD, FACP||Case Comprehensive Cancer Center|
|Principal Investigator:||Eric Klein, MD||Case Comprehensive Cancer Center|