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.
- 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
- 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)
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Lawrence Fong, MD
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|