Phase II Randomized Study of Vaccine Treatment of Advanced Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven prostate cancer limited to the prostate
(including seminal vesicle and/or local lymph node involvement) with elevated PSA (greater
than 2 ng/ml) following surgery or rising PSA following radiotherapy Negative bone scan
and CT scan of abdomen and pelvis No PSA progression during chemotherapy, hormonal therapy
(including steroids), or neoadjuvant or adjuvant androgen ablation therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At
least 6 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3
Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal Bilirubin no greater
than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at
least 50 mL/min Cardiovascular: Not specified Pulmonary: Not specified Other: No active
untreated infection No known infection with HIV No concurrent medical conditions that
would prevent compliance No history or evidence of active eczema or psoriasis or other
contraindications to vaccinia virus administration (i.e., allergy) No significant allergy
or hypersensitivity to eggs No evidence of immunosuppression Must be able to avoid contact
with high risk individuals (immunosuppressed patients, children under 3, pregnant women,
or patients with a history of or active eczema or other exfoliative diseases) for 7-10
days after immunization (household contacts must not be high risk) Fertile patients must
use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 6 months since prior chemotherapy and recovered Endocrine
therapy: See Disease Characteristics At least 6 months since prior hormonal therapy
(including steroids) and recovered Radiotherapy: See Disease Characteristics At least 3
months since prior radiotherapy of prostate and recovered Surgery: See Disease
Characteristics At least 3 months since prior prostate surgery and recovered Other: Prior
vaccinia immunization required OR Patient recollection of immunization and appropriate
vaccination site scar