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