Spots Global Cancer Trial Database for GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer

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Trial Identification

Brief Title: GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer

Official Title: Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy

Study ID: NCT00400517

Conditions

Prostate Cancer

Interventions

Study Description

Brief Summary: 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.

Detailed Description: 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.