Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Brief summary
RATIONALE: Vaccines made from a patient's white blood cells may make the body build an immune response to kill cancer cells. Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-12 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy combined with interleukin-12 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Detailed description
OBJECTIVES: * Determine whether immunization with prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells and interleukin-12 can promote specific T-cell priming in patients with metastatic hormone-refractory prostate cancer. * Determine the clinical response in patients treated with this regimen. OUTLINE: Patients receive prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells subcutaneously (SC) on day 1 and interleukin-12 SC on days 1, 3, and 5. Treatment repeats every 21 days for 3-9 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 37 weeks.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the prostate * HLA-A2 positive * Progressive measurable systemic disease * PSA at least 5 ng/mL with 2 consecutive rising PSA levels at least 1 week apart and no measurable disease OR * Objective evidence of disease progression by a 20% increase in the sum of longest diameter of all target lesions or evidence of new lesions by CT or bone scan regardless of PSA status * Lesions must be at least 1 cm to be considered measurable * Progressive systemic disease after discontinuation of anti-androgen therapy * Previously treated with orchiectomy (testosterone less than 50 ng/mL) OR luteinizing hormone-releasing hormone (LHRH) analogue therapy with or without anti-androgens * If on LHRH analogue therapy, must continue therapy during study * Brain metastases allowed if previously treated, clinically stable, and weaned from prior corticosteroids PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 70-100% Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Hemoglobin greater than 9 g/dL * Platelet count greater than 100,000/mm\^3 * No active gastrointestinal bleeding Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGPT normal * Hepatitis B surface antigen negative Renal: * Creatinine less than 1.5 times ULN * Calcium less than 11 mg/dL Cardiovascular: * No significant cardiovascular disease * No cardiac arrhythmia requiring therapy Other: * Fertile patients must use effective barrier contraception * No intrinsic immunosuppression * HIV negative * No serious concurrent infection * No psychiatric illness that would preclude study compliance * No clinically significant autoimmune disease * No uncontrolled peptic ulcer disease * No history of inflammatory bowel disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy Chemotherapy: * Not specified Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior flutamide * At least 6 weeks since prior bicalutamide or nilutamide * No concurrent systemic corticosteroids except physiologic replacement doses Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * No concurrent immunosuppressive drugs (e.g., cyclosporine)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease response | 63 days |
Countries
United States