Vaccine Therapy Plus Sargramostim and Interleukin-2 Compared With Nilutamide Alone in Treating Patients With Prostate Cancer

DISEASE CHARACTERISTICS:

Histologically confirmed hormone-refractory adenocarcinoma of the prostate

Rising PSA after orchiectomy and/or while receiving at least 1 regimen of luteinizing hormone-releasing hormone (LHRH)
PSA must have risen at least 0.5 ng/mL from baseline on 2 successive measurements during and/or after hormonal therapy
PSA greater than 1.0 ng/mL
If on antiandrogen therapy, must undergo antiandrogen withdrawal for at least 6 weeks and still have evidence of rising PSA
After prior bicalutamide, must undergo withdrawal for at least 6 weeks and still have evidence of rising PSA
Testosterone no greater than 50 ng/mL if no prior orchiectomy
No metastatic disease by bone scan and CT scan or MRI of the abdomen and pelvis and by CT scan or x-ray of the chest
No active or prior CNS metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Zubrod 0-2 OR
ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

Absolute lymphocyte count at least 600/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 8.0 g/dL

Hepatic:

Bilirubin no greater than 1.6 mg/dL
AST and ALT no greater than 4 times normal

Renal:

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance greater than 60 mL/min
Urinalysis normal OR
Proteinuria no greater than 1 g/24-hour urine collection
No hematuria or abnormal sediment unless underlying cause is nonrenal

Immunologic:

HIV negative
No altered immune function

No autoimmune disease, including the following:

Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
Systemic lupus erythematosus, Sjogren's syndrome, or scleroderma
Myasthenia gravis
Goodpasture syndrome
Addison's disease, Hashimoto's thyroiditis, or active Graves' disease
No known allergy or untoward reaction to prior vaccination with vaccinia virus
No known allergy to eggs
No active or prior eczema or other eczematoid skin disorders
No other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, impetigo, varicella zoster, burns, severe acne, or other open rashes or wounds)

Other:

No other serious concurrent illness
No active infections within the past 3 days
No history of seizures, encephalitis, or multiple sclerosis

No close or household contact for at least 2 weeks after each vaccinia virus inoculation with the following high-risk individuals:

Children under 5 years of age
Pregnant or nursing women
Individuals with active or prior eczema or other eczematoid skin disorders, atopic dermatitis, impetigo, varicella zoster, burns, severe acne, or other open rashes or wounds
Immunosuppressed or immunodeficient (by disease or therapy) individuals, including those with HIV infection
No other malignancy within the past 3 years except squamous cell or basal cell skin cancer or other curatively treated malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Must have prior vaccinia for smallpox immunization
No other concurrent biologic therapy

Chemotherapy:

No prior chemotherapy for prostate cancer
No concurrent chemotherapy

Endocrine therapy:

See Disease Characteristics
At least 4 weeks since prior hormonal therapy (6 weeks for bicalutamide) and recovered
If disease progression on LHRH antagonist, must continue to receive that LHRH agent or undergo surgical castration
No concurrent steroids unless topical or inhaled
No other concurrent hormonal therapy

Radiotherapy:

At least 4 weeks since prior radiotherapy and recovered
No prior radiotherapy to more than 50% of nodal groups
No concurrent radiotherapy

Surgery:

See Disease Characteristics
See Endocrine therapy
At least 4 weeks since prior surgery and recovered
No prior splenectomy

Other:

No concurrent homeopathic therapy with PC-SPES or genistein