A Randomized Phase II Study of Immunization Against Melanoma Comparing Autologous Dendritic Cells Pulsed With gp100 Peptide to Autologous Dendritic Cells Fused With Autologous Tumor Cells
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Immune response
研究概览
简要总结
RATIONALE: Vaccines made from a patient's dendritic cells may make the body build an immune response to kill tumor cells. It is not yet known whether combining vaccine therapy with either gp100 antigen or the patient's tumor cells will cause a stronger immune response and kill more tumor cells.
PURPOSE: This randomized phase II trial is studying vaccine therapy and gp100 antigen to see how well they work compared to vaccine therapy and patient's tumor cells in treating patients with stage III or stage IV melanoma.
详细描述
OBJECTIVES:
Primary
- Compare the tumor-specific immune response, in terms of the number of gp100-specific cytotoxic T-lymphocytes, T-cell production of interferon gamma, or T-cell proliferation in response to in vitro exposure to gp100 and tumor lysate, in patients with stage III or IV melanoma treated with autologous dendritic cells (DC) pulsed with gp100 antigen vs autologous DC fused with autologous tumor cells.
Secondary
- Compare the safety and toxicity of these regimens in these patients.
- Compare the therapeutic effect of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed cutaneous melanoma
- •Stage III or IV disease
- •Recurrent or de novo stage III disease allowed if disease is unresectable and no definitive treatment is available
- •gp100- and HLA-A201-positive
- •Surgically accessible tumor, defined by 1 of the following:
- •Pulmonary lesions approachable by thoracoscopic procedure
- •Skin or superficial soft tissue or lymph node lesions amenable to resection under local anesthesia
- •Malignant ascites or pleural effusion
- •Measurable disease in addition to surgically accessible tumor > 2.0 cm
- •No CNS metastases
- •No mucosal or ocular melanoma
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •WBC > 3,000/mm^3
- •Platelet count > 75,000/mm^3
- •Bilirubin < 2.0 mg/dL
- •Creatinine < 2.0 mg/dL
- •Immunologic
- •No active infection requiring treatment
- •No clinically significant autoimmune disorder
- •No immune deficiency disorder
- •HIV negative
- •Antecubital vein accessible for leukapheresis
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or squamous cell carcinoma in situ of the cervix
- •No pre-existing comorbid disease that would preclude study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior melanoma vaccine therapy
- •More than 6 weeks since prior immunotherapy
- •Chemotherapy
- •No prior chemotherapy for metastatic melanoma
- •Endocrine therapy
- •No concurrent corticosteroids
- •Radiotherapy
- •More than 6 weeks since prior radiotherapy
- •Not specified
- •No concurrent systemic immunosuppressive therapy
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo surgical harvesting of tumor cells for subsequent fusion. Patients receive vaccination comprising dendritic cells (DC) fused with autologous tumor cells subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who achieve a partial (PR) or complete response (CR) may receive an additional 3 courses.
干预措施: autologous dendritic cell-tumor fusion vaccine (Biological)
Arm II
Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may receive an additional 6 courses.
干预措施: therapeutic autologous dendritic cells (Biological)
Arm II
Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may receive an additional 6 courses.
干预措施: gp100 antigen (Biological)
结局指标
主要结局
Immune response
次要结局
未报告次要终点