Treatment of Patients With Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response and kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.
详细描述
OBJECTIVES:
- Determine whether reinfused activated cells alone or in conjunction with high or subcutaneous dose interleukin-2 may result in clinical tumor regression in patients with metastatic melanoma who had previously failed therapy on protocols involving immunization against the gp100 molecule.
- Determine the survival of infused cells with antitumor activity in these patients.
OUTLINE: This is a salvage regimen.
Patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy to obtain tumor infiltrating lymphocytes (TIL). Cells are incubated in the presence of gp209-2M peptide and then harvested and cloned. Patients receive 30-minute IV infusions of these in vitro sensitized cells. Treatment repeats every 2 weeks for 2 courses. An additional cohort of 8 patients receives gp209-2M peptide in Montanide ISA-51 subcutaneously in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes. At 4 to 6 weeks after the treatment courses, patients with stable or regressing disease may be retreated.
Patients with disease progression after 2 courses may receive 2 additional courses of cell infusion followed by interleukin-2 (IL-2) on one of two schedules. One cohort of patients receives IL-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after cell infusion and continuing for up to 5 days of each treatment course. Another cohort receives IL-2 by daily subcutaneous injections on days 1-12 of each course of therapy. If after 12-16 patients have been treated with cloned cells alone initially and responses are inadequate, subsequent patients entered into this study are randomized to receive the cell infusion followed by IL-2 on one of the two described schedules.
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 proven metastatic melanoma that has failed therapy on protocols involving immunization against the gp100 molecule
- •Measurable or evaluable metastatic disease
- •Must be HLA-A201 positive by standard HLA typing
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Greater than 3 months
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,000/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
- •ALT/AST less than 4 times upper limit of normal
- •Creatinine no greater than 1.6 mg/dL
- •Cardiovascular:
- •For patients randomized to receive interleukin-2:
- •No major medical illnesses of the cardiovascular system
- •For patients randomized to receive interleukin-2:
- •No major medical illnesses of the pulmonary system
- •HIV negative
- •Hepatitis B antigen negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •For patients randomized to receive interleukin-2:
- •No active systemic infection
- •No other major medical illnesses of immune system
- •No coagulation disorders
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior biologic therapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy
- •Endocrine therapy:
- •No concurrent steroid therapy
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •Not specified
- •No concurrent active treatment of brain metastases
排除标准
- 未提供