GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer
RATIONALE: Colony-stimulating factors, such as GM-CSF, may help the body build an effective immune response to kill tumor cells. Giving GM-CSF before surgery may be an effective treatment for localized prostate cancer.
PURPOSE: This clinical trial is studying how well giving GM-CSF before surgery works in treating patients with localized prostate cancer.
Other: immunohistochemistry staining method
Other: immunological diagnostic method
Other: laboratory biomarker analysis
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Two Dose Schedules of Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) as Neo-Adjuvant Therapy in Patients With Localized Prostate Cancer|
- Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy. [ Time Frame: up to 6 weeks following surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2006|
|Study Completion Date:||June 2014|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: GM-CSF before surgery
GM-CSF dose prior to surgery- Cohort 1-GM-CSF 250mcg/m2 for 2 weeks Cohort 2-GM-CSF 250mcg/m2 for 3 weeks Cohort 3-GM-CSF 250mcg/m2 for 4 weeks Cohort 4-GM-CSF 125mcg/m2 for 4 weeks
|Biological: sargramostim Other: immunohistochemistry staining method Other: immunological diagnostic method Other: laboratory biomarker analysis Procedure: conventional surgery Procedure: neoadjuvant therapy|
- Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy.
- Determine whether tissue-specific antiprostate cancer immunity is induced by the administration of neoadjuvant GM-CSF in patients with localized prostate cancer prior to radical prostatectomy.
- Estimate the baseline antitumor immune response in patients treated with 2 different dose schedules of GM-CSF.
- Determine the magnitude of the difference in immune response between 2 dose schedules of GM-CSF.
- Determine the clinical effects, including prostate-specific antigen (PSA) decline, surgical outcome, surgical complications, and histologic appearance of surgical specimen, of this regimen in these patients.
OUTLINE: This is a pilot study. Patients are stratified according to sargramostim (GM-CSF) dose.
Patients receive 1 of 2 dose levels of GM-CSF subcutaneously on days 1-14 or 1-21. Treatment continues in the absence of unacceptable toxicity. Within 3 days after the last dose of GM-CSF, patients undergo radical prostatectomy.
Blood is collected at baseline, day 28 of each course, and at the 4-week follow-up visit and is examined for activated T-cells. Tissue is collected during surgery and assessed for biomarkers and cytokines.
After completion of study treatment, patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305669
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Lawrence Fong, MD||University of California, San Francisco|