NCT00010127终止1 期
A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •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
- •Creatinine less than 2.5 mg/dL
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •No asthma
- •No chronic obstructive pulmonary disease
- •No severe lung disease
- •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:
- 另有 9 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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