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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Vaccines made from prostate cancer cells may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill prostate cancer cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using nilutamide may fight prostate cancer by reducing the production of androgens. It is not yet known which treatment regimen is more effective for treating prostate cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus sargramostim and interleukin-2 with that of nilutamide alone in treating patients who have prostate cancer that has not responded to hormone therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Nilutamide; Sargramostim; Vaccines

Criteria

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