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

Inclusion 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