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Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy. Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Participants frequently get the best healthcare available for their Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy  Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: stage 4 prostate cancer,adenocarcinoma of the prostate,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasGajewski, Study Chair, University of Chicago Cancer Research Center
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Additional Information:
Study ID Numbers: CDR0000068578; NCI-1192,UCCRC-9845
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015977
Other Stage 4 Prostate Cancer Studies:
1. Hormone Therapy Followed By Internal Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer
2. Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
3. MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer
4. Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
5. Biological Therapy in Treating Patients With Prostate Cancer
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
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