NCT00058279已完成1 期
MDX-CTLA4 Combined With IL-2 for Patients With Metastatic Melanoma
适应症
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: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining monoclonal antibody therapy with interleukin-2 may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining monoclonal antibody therapy with interleukin-2 in treating patients who have metastatic melanoma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) in combination with high-dose interleukin-2 (IL-2) in patients with metastatic melanoma. (Phase I is closed to accrual as of 4/13/2004).
- Determine the activity of MDX-CTLA4 administered at the MTD with high-dose IL-2 in these patients.
- Determine whether the administration of IL-2 alters the pharmacokinetics of MDX-CTLA4 in these patients.
- Determine the safety and adverse event profile of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4).
- Phase I: Patients receive MDX-CTLA4 IV on days 0, 21, and 42. Patients also receive high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours for up to 15 doses beginning on days 22 and 43. Treatment repeats every 63 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with an ongoing partial response and no greater than grade 1 toxicity may receive additional courses of therapy. Patients who require discontinuation of MDX-CTLA4 due to toxicity may continue receiving IL-2 at the discretion of the investigator.
Cohorts of 3-6 patients receive escalating doses of MDX-CTLA4 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. (Phase I is closed to accrual as of 4/13/2004).
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage IV melanoma
- •Mucosal or ocular melanoma also eligible
- •Clinically evaluable disease
- •At least 1 site of measurable disease
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •WBC at least 2,500/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Hematocrit at least 30%
- •Bilirubin no greater than upper limit of normal (ULN)* (less than 3.0 mg/dL in patients with Gilbert's syndrome)
- •AST no greater than 3 times ULN*
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody nonreactive
- •No evidence or history of significant hepatic disease that would preclude safe administration of high-dose IL-2 NOTE: *Unless attributable to disease
- •Creatinine no greater than 2.0 mg/dL
- •No evidence or history of significant renal disease that would preclude safe administration of high-dose IL-2
- •Cardiovascular
- •No evidence or history of significant cardiac disease that would preclude safe administration of high-dose IL-2
- •Thallium stress test normal (for patients over 50 years of age or with a history of cardiovascular disease)
- •No evidence or history of significant pulmonary disease that would preclude safe administration of high-dose IL-2
- •Immunologic
- •HIV negative
- •No autoimmune disease (including uveitis and autoimmune inflammatory eye disease)
- •No active infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- •No evidence or history of significant gastrointestinal disease that would preclude safe administration of high-dose IL-2
- •No evidence or history of psychiatric disease that would preclude safe administration of high-dose IL-2
- •No other underlying medical condition that would make the administration of the study drug hazardous or obscure the interpretation of adverse events
- •No other concurrent medical condition that would preclude study entry
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 3 weeks since prior immunotherapy for melanoma and recovered
- •No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4)
- •No prior high-dose (at least 600,000 IU/kg every 8 hours) interleukin-2 (IL-2)
- •Chemotherapy
- •At least 3 weeks since prior chemotherapy for melanoma and recovered
- •No concurrent chemotherapy
- •Endocrine therapy
- •At least 3 weeks since prior hormonal therapy for melanoma and recovered
- •At least 4 weeks since prior corticosteroids
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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