GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer

Prostate Cancer Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

OBJECTIVES:

Primary

• 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.

Secondary

• 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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00305669
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: Phase 1
• Start date: July 2006
• Completion date: June 2014