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Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer  Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
For Condition: adenocarcinoma of the prostate,stage 4 prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Duke Comprehensive Cancer Center
Synopsis: RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill prostate tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer.
Details: OBJECTIVES: I. Determine the safety and feasibility of autologous dendritic cells transfected with autologous total tumor RNA in patients with metastatic prostate cancer. II. Determine the presence, frequency, and activation status of tumor specific and prostate specific antigen (PSA) specific cellular immune responses in patients treated with this regimen. III. Determine delayed-type hypersensitivity reactions to PSA protein and other recall antigens in patients before and after being treated with this regimen. IV. Determine clinical responses based on clinical and biochemical (PSA) response criteria in patients treated with this regimen. V. Determine a platform for immunological treatment using dendritic-cell based tumor vaccines in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Tumor tissue and peripheral blood stem cells are collected from patients and cultured in vitro with sargramostim (GM-CSF) and interleukin-4 for 7 days to produce dendritic cells (DC). Patients receive autologous DC transfected with autologous prostate carcinoma RNA intradermally once weekly on weeks 0-3 for a total of 4 doses. Cohorts of 3-6 patients receive escalating doses of DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at weeks 6, 8, 10, and 12; every 3 months for 9 months; and then annually for 2 years. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed metastatic adenocarcinoma of the prostate - Stage D1-3 - Regional lymph node, bone, visceral, or soft tissue metastases - No transitional cell or small cell carcinoma Testosterone less than 50 mg/L if prior treatment with luteinizing hormone releasing hormone (LHRH) analogues or estrogens Evidence of androgen refractory disease after surgical castration and discontinuation of LHRH analogue therapy No previously irradiated or new CNS metastases --Prior/Concurrent Therapy-- Biologic therapy: - Prior biologic therapy allowed - No other concurrent immunotherapy Chemotherapy: - Prior chemotherapy allowed - No concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - At least 4 weeks since prior non-steroidal hormonal therapy if increase in PSA while receiving non-steroidal hormonal therapy - At least 6 weeks since prior steroids - Concurrent LHRH analogues for gonadal androgen suppression allowed - No concurrent steroid therapy - No concurrent corticosteroids Radiotherapy: - See Disease Characteristics - Prior palliative radiotherapy for bone metastases allowed - Prior prostatic radiotherapy allowed - At least 4 weeks since prior radiotherapy - At least 12 weeks since prior strontium chloride Sr 89 - No concurrent radiotherapy Surgery: See Disease Characteristics Other: - Recovered from prior therapy - No concurrent immunosuppressive agents (e.g., azathioprine or cyclosporine) --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 6 months Hematopoietic: - WBC at least 3,000/mm3 - Hemoglobin at least 9 g/dL - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin less than 2.0 mg/dL - PT at least 11.3 seconds but no greater than 13.3 seconds - PTT at least 20.1 seconds but no greater than 32.9 seconds - No hepatic disease - No viral hepatitis Renal: Creatinine less than 2.5 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Pulmonary: - No asthma - No chronic obstructive pulmonary disease - No severe lung disease Other: - No other medical illness or psychological impediment that would preclude study - No other concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer - No active acute or chronic infection including symptomatic urinary tract infection - No autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis) - HIV negative - Adequate peripheral vein access
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohannesVieweg, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000068447; DUMC-000759-00-4R1,DUMC-DORIS-99043,NCI-G00-1910
Study Start Date: November 2000
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010127
Other Adenocarcinoma Of The Prostate Studies:
1. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
2. BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer
3. Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
4. Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
5. Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
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