gm-csf before surgery in treating patients with localized prostate cancer

Conditions: Prostate Cancer

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.

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.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed adenocarcinoma of the prostate * no neuroendocrine or small cell features * no evidence of metastatic disease * planning radical prostatectomy at least 2 months from now * testosterone level normal patient characteristics: * ecog performance status (ps) 0-1 or karnofsky ps 70-100% * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 8 g/dl * ast and alt ≤ 1.5 times upper limit of normal (uln) * bilirubin ≤ 1.5 times uln * creatinine ≤ 1.5 times uln * pt and ptt normal * fertile patients must use effective barrier contraception * no history of allergic reaction to compounds of similar chemical or biologic composition to sargramostim (gm-csf) * no ongoing or active bacterial, viral, or fungal infection * dlco \> 50% if patient has a history of clinically significant obstructive airway disease * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia * no other active malignancy, defined as cancer for which therapy has been completed and patient is now considered \< 30% risk of relapse, except nonmelanoma skin cancer * no psychiatric illness or social situation that would preclude study compliance * no other uncontrolled illness * no underlying medical condition that, in the opinion of the principal investigator, may make the administration of gm-csf hazardous or obscure the interpretation of adverse events prior concurrent therapy: * more than 4 weeks since prior major surgery * no prior radiotherapy, immunotherapy, chemotherapy, or other investigational therapy for this cancer * no prior hormonal therapy including any of the following: * luteinizing-hormone releasing hormone (lhrh) agonists * lhrh antagonists * antiandrogens, including any of the following: * bilcalutamide * flutamide * nilutamide * 5-alpha-reductase inhibitors * pc-spes or other pc-x product * estrogen-containing nutriceuticals * no concurrent chemotherapy or radiotherapy * no concurrent systemic steroid therapy * concurrent inhaled or topical steroids allowed * no other concurrent immunotherapy * no other concurrent investigational agent * no other concurrent anticancer agents or therapies

Keywords: adenocarcinoma of the prostate stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer