NCT00295958已完成2 期
Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Objective clinical response rate
研究概览
简要总结
RATIONALE: The LMB-2 immunotoxin can find tumor cells and kill them without harming normal cells. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving LMB-2 immunotoxin together with vaccine therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving LMB-2 immunotoxin together with vaccine therapy works in treating patients with metastatic melanoma that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine objective clinical response in patients with progressive, unresectable metastatic melanoma treated with recombinant LMB-2 immunotoxin and peptide vaccination comprising gp100:209-217 (210M) antigen, MART-1:27-35 antigen, and Montanide ISA-51.
Secondary
- Determine changes in levels of CD4+, CD25+ regulatory T cells in peripheral blood before and after treatment in patients treated with this regimen.
- Determine the ability of recombinant immunotoxin LMB-2 to augment peptide vaccination in these patients.
- Determine the toxicity profile of this regimen in these patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of metastatic melanoma
- •Unresectable disease
- •Progressive disease while receiving standard therapy (e.g., interleukin-2 or dacarbazine)
- •HLA-A0201 positive
- •Measurable disease
- •The following are not allowed:
- •Resectable local/regional disease
- •Patients whose serum neutralizes LMB-2 in tissue culture, due either to antitoxin or antimouse-immunoglobulin G antibodies (> 75% of the activity of 1 ug/mL of LMB-2)
- •Received LMB-2 on another trial
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy more than 3 months
- •WBC ≥ 3,000/mm^3
- •Absolute lymphocyte count > 500/mm^3
- •Platelet count ≥ 90,000/mm^3
- •Bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with Gilbert's syndrome)
- •AST and ALT ≤ 2.5 times normal
- •Albumin ≥ 3.0 g/dL
- •No hepatitis B surface antigen or hepatitis C positivity
- •Creatinine ≤ 1.4 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No ongoing or active infection
- •Ejection fraction ≥ 45% by echocardiogram or thallium stress test (for patients > 50 years of age OR who have a history of cardiovascular disease)
- •LVEF ≥ 45%
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •No known HIV positivity
- •No autoimmune disease
- •No immunodeficiency
- •No other malignancies
- •Must be willing to undergo leukapheresis
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 12 weeks since prior monoclonal antibody therapy
- •More than 3 weeks since prior and no concurrent systemic therapy for cancer
- •No concurrent chronic anticoagulant therapy
- •No concurrent systemic steroid therapy
排除标准
- 未提供
结局指标
主要结局
Objective clinical response rate
次要结局
- Changes in levels of CD4+, CD25+ regulatory T cells
- Ability of LMB-2 to augment peptide vaccination
- Toxicity
研究者
研究点 (2)
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