NCT00006981已完成1 期
Phase I Study Of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion X 10 Days
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: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be an effective treatment for advanced cancer.
PURPOSE: Phase I trial to study the effectiveness of immunotoxins in treating patients who have advanced cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and toxic effects of SS1(dsFv)-PE38 immunotoxin in patients with advanced malignancies that express mesothelin.
Secondary
- Determine the response in patients treated with this drug.
- Determine the plasma pharmacokinetics of this drug 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:
- •Histologically confirmed malignancy, including one of the following:
- •Malignant mesothelioma
- •Ovarian epithelial carcinoma (mucinous or nonmucinous), including primary peritoneal or fallopian tube carcinoma
- •Tumors that may have originated in the bowel (e.g., appendiceal carcinoma) and involve the ovary
- •Ovarian cancers of other histology are eligible provided they express mesothelin
- •Pancreatic cancer
- •Squamous cell lung cancer
- •Squamous cell cancer of the head and neck
- •Squamous cell cancer of the cervix
- •Recurrent unresectable disease after prior standard anticancer therapy that was expected to prolong survival and improve quality of life OR unwilling to receive standard anticancer therapy
- •At least 30% of initial or recurrent tumor cells positive (at least 1+) for mesothelin by immunohistochemistry
- •Measurable or evaluable disease
- •No known CNS or spinal cord involvement
- •No clinically significant pericardial effusion
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,000/mm^3
- •Platelet count at least 75,000/mm^3
- •Bilirubin no greater than upper limit of normal (ULN)
- •AST and ALT no greater than 2.5 times ULN
- •Albumin at least 3.0 g/dL
- •Hepatitis B and C negative
- •Creatinine no greater than ULN OR
- •Creatinine no greater than 2.0 mg/dL if creatinine clearance at least 50 mL/min
- •Calcium no greater than ULN
- •Cardiovascular:
- •No New York Heart Association class II-IV heart disease
- •Oxygen saturation (SO_2) more than 92% on room air
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No detectable antibody to SS1(dsFv)-PE38
- •No infection requiring parenteral antibiotics
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 1 week since prior hematopoietic growth factor therapy
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •At least 4 weeks since any prior antitumor therapy and recovered
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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