Expired Study
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Durham, North Carolina 27710


Purpose:

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.


Study summary:

OBJECTIVES: - Determine the safety and feasibility of autologous dendritic cells transfected with autologous total tumor RNA in patients with metastatic prostate cancer. - 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. - Determine delayed-type hypersensitivity reactions to PSA protein and other recall antigens in patients before and after being treated with this regimen. - Determine clinical responses based on clinical and biochemical (PSA) response criteria in patients treated with this regimen. - Determine a platform for immunological treatment using dendritic-cell based tumor vaccines in these patients. 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.


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 PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - More than 6 months Hematopoietic: - WBC at least 3,000/mm^3 - Hemoglobin at least 9 g/dL - Platelet count at least 100,000/mm^3 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 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)


NCT ID:

NCT00010127


Primary Contact:

Study Chair
Johannes Vieweg, MD
Duke Cancer Institute


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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