Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: PSA prostate cancer vaccine
* Biological: recombinant interleukin-12


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSMA peptide vaccine<br>Immunization with PSMA peptide vaccine followed by injection of Interleukin-12 (IL-12) on Day 1 of a 21-day cycle. Additional injections of IL-12 given on Days 3 and 5 of each cycle. | Biological: PSA prostate cancer vaccine<br> <br> Biological: recombinant interleukin-12<br> <br> * Other names: IL-12, rhIL-12;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease response |  | 63 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer