Phase I/II Study in Patients With Metastatic Melanoma of Immunization With Dendritic Cells Presenting Epitopes Derived From The Melanoma Associated Antigens MART-1 and gp 100
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Vaccines made from white blood cells treated with antigens may make the body build an immune response to kill melanoma cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may kill more melanoma cells.
PURPOSE: This phase I/II trial is studying the side effects and how well giving vaccine therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with metastatic melanoma that has not responded to previous therapy.
详细描述
OBJECTIVES:
- Evaluate the toxicity, immunologic reactivity, and possible therapeutic efficacy of immunization with dendritic cells presenting the MART-1 and gp100 melanoma antigens with or without interleukin-2 in patients with metastatic melanoma.
OUTLINE: This is a dose-escalation study of dendritic cells pulsed with MART-1 and gp100 antigens.
Patients receive vaccinations with dendritic cells pulsed with MART-1 and gp100 antigens, either intralymphatically every 4 weeks for 2 doses, or IV every 3 weeks for 4 doses. Some patients also receive interleukin-2 subcutaneously or IV, over 3-5 days, beginning 24 hours after immunization.
Cohorts of 2-9 patients receive escalating doses of pulsed dendritic cells IV until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Subsequent cohorts receive cells with or without interleukin-2. One cohort may expand to 15 patients to determine the accuracy of immunologic response to the vaccine.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic melanoma that has failed standard effective therapy
- •Measurable or evaluable disease
- •HLA-A2 positive
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 8.0 g/dL
- •Bilirubin no greater than 2.0 mg/dL
- •AST/ALT less than 4 times upper limit of normal
- •Negative hepatitis B surface antigen
- •No coagulation disorder
- •Creatinine no greater than 1.6 mg/dL OR
- •Creatinine clearance greater than 75 mL/min
- •Cardiovascular:
- •No major cardiovascular disease
- •No major respiratory disease
- •No major immunological disease
- •No penicillin allergy
- •HIV negative
- •No active systemic infection
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •At least 4 weeks since prior steroid therapy and recovered
- •Radiotherapy
- •Not specified
- •Not specified
- •More than 4 weeks since any other prior therapy and recovered
排除标准
- 未提供