NCT00066651已完成1 期
Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
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 effective in treating advanced solid tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of immunotoxin therapy in treating patients with recurrent unresectable advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of SS1(dsFv)-PE38 immunotoxin in patients with advanced mesothelin-expressing malignancies.
Secondary
- Determine the toxic effects of this drug in these patients.
- Determine the plasma pharmacokinetics of this drug in these patients.
- Determine the response in patients treated with this drug.
- Correlate the induction of antibody against this drug with its pharmacokinetics 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 advanced malignancy of 1 of the following types:
- •Ovarian cancer
- •All nonmucinous epithelial histologies are eligible
- •Primary peritoneal cavity cancer
- •Fallopian tube cancer
- •Malignant mesothelioma
- •No sarcomatous histology
- •Pancreatic cancer
- •Squamous cell cancer (SCC) of the lung
- •SCC of the cervix
- •SCC of the head and neck
- •Recurrent unresectable disease, meeting 1 of the following criteria:
- •Previously treated with definitive standard therapy
- •Patient refused prior standard therapy
- •Initial or recurrent tumor positive (at least 30% of tumor cells) for mesothelin by immunohistochemistry* NOTE: *Immunohistochemical evaluation not required for patients with pancreatic cancer
- •Measurable or evaluable disease
- •No clinically significant pericardial effusion
- •No known CNS or spinal cord involvement by tumor
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/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
- •Seropositive allowed if clinically asymptomatic
- •except if clinically asymptomatic and bilirubin and AST and ALT meet the outlined criteria
- •Creatinine no greater than ULN
- •Calcium no greater than ULN
- •Cardiovascular
- •No New York Heart Association class II-IV cardiovascular disease
- •Oxygen saturation at least 93% on room air
- •DLCO at least 50% of predicted*
- •Total lung capacity and vital capacity at least 50% of predicted*
- •FEV_1 at least 50% of predicted* NOTE: *For patients with pleural mesothelioma and as clinically indicated
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No infection requiring parenteral antibiotics
- •No HIV infection
- •Serum neutralizing activity to SS1(dsFv)-PE38 immunotoxin (at 200 ng/mL) no greater than 75%
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- 另有 9 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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