Spots Global Cancer Trial Database for GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer

Study Description

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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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