Expired Study
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Chicago, Illinois 60637


Purpose:

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.


Study summary:

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.


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)


NCT ID:

NCT00015977


Primary Contact:

Study Chair
Thomas F. Gajewski, MD, PhD
University of Chicago


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60637
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 22, 2017

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