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:||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 [ Designated as safety issue: No ]
- Proportion of patients with negative surgical margins [ Designated as safety issue: No ]
- Prostate-specific antigen response [ Designated as safety issue: No ]
- Time to clinical progression [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
- 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|