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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Biological: sargramostim; Other: immunohistochemistry staining method; Other: immunological diagnostic method; Other: laboratory biomarker analysis; Procedure: conventional surgery; Procedure: neoadjuvant therapy

• Registration Number: NCT00305669
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-22
• Study Start: 2006-07
• Primary Completion: 2011-01
• Status Verified: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GM-CSF before surgery	sargramostim	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
GM-CSF before surgery	immunohistochemistry staining method	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
GM-CSF before surgery	immunological diagnostic method	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
GM-CSF before surgery	laboratory biomarker analysis	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
GM-CSF before surgery	conventional 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
GM-CSF before surgery	neoadjuvant therapy	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

Primary Outcome Measures

Name	Time	Method
Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy.	up to 6 weeks following surgery

Trial Locations

Locations (1)

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States