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

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
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
Sites / Locations
- UCSF Helen Diller Family Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
GM-CSF before 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