Study of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: IV Infusion QOD x Six Doses
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
研究概览
简要总结
Although Neopharm has terminated its sponsorship of this study, it is continuing under the sponsorship of the NCI. Please contact Raffit Hassan, MD at 301-451-8742 for more information. Also see the related NCI study "Experimental Drug SS1(dsFv)-PE38 to Treat Cancer" (Study ID number 010011).
SS1(dsFv)-PE38 is an oncology drug product containing a bacteria toxin, fused to a high affinity, disulfide stabilized antibody. The fused protein retains cell killing activity, but binds only to cells expressing mesothelin. Tumors characterized by very high surface mesothelin expression include mesothelioma; epithelial carcinomas of ovary and peritoneum; and squamous cancers of cervix and upper aerodigestive tract, including esophagus, head, and neck cancers.
This is a dose-escalating study to determine the maximum tolerated dose (MTD) of intravenous SS1(dsFv)-PE38 administered once every other day for six doses. Dose escalation will proceed in cohorts of 3 until dose-limiting toxicity (DLT) is observed.
详细描述
OBJECTIVES: I. Determine the toxicities and maximum tolerated dose (MTD) of six doses of SS1(dsFv)-PE38 QOD administered by intravenous infusion to patients with advanced malignancies.
II. Characterize the plasma pharmacokinetics of SS1(dsFv)-PE38 after intravenous infusion.
III. Determine toxicities attributable to subsequent courses of SS1(dsFv)-PE38.
IV. Evaluate the response of selected advanced malignancies to intravenous infusion of six doses of SS1(dsFv)-PE38 QOD administered at the MTD.
V. Determine the induction of antibody against SS1(dsFv)-PE38 and its relationship to pharmacokinetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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-
- •Histopathologic diagnosis of one of the following malignancies: ovarian carcinoma, all non-mucinous epithelial histologies, including primary peritoneal and fallopian tube carcinoma; malignant mesothelioma, except sarcomatous histology; squamous cell cancer of the lung; squamous cell cancer of the cervix; or squamous cell cancer of the head and neck.
- •Tissue block must be available for analysis. Tumor, initial or recurrent, must be positive (at least 30% of tumor cells) for mesothelin by immunohistochemistry.
- •Recurrent unresectable disease after appropriate definitive therapy.
- •At least 4 weeks elapsed since any prior therapy, with recovery from side effects. No concurrent anti-tumor treatment of any kind.
- •Measurable or evaluable tumor documented within 4 weeks prior to study entry.
- •Patient Characteristics-
- •At least 18 years of age.
- •At least 12-week life expectancy.
- •Performance Status (ECOG) 0-
- •Adequate organ function, including: Absolute neutrophil count at least 1,500/mm3; Platelets at least 75,000/mm3; Creatinine, Calcium, and total Bilirubin less than or equal to the upper limit of normal; Liver enzymes AST and ALT less than or equal 2.5 x the upper limit of normal; Albumin at least 3.0 g/dL; Oxygen (O2) saturation more than 93% (room air).
- •Informed Consent signed in accordance with institutional criteria.
- •No known central nervous system (CNS) or spinal cord involvement by tumor.
- •No detectable antibody to SS1(dsFv)-PE
- •No concurrent antitumor therapy.
- •No cardiovascular condition NY Heart Association Grade II-IV, or any clinically-significant pericardial effusion.
- •No infection requiring parenteral antibiotics; no HIV infection; and no seropositivity for Hepatitis B and Hepatitis C.
- •Must not be pregnant or nursing. Females of child-bearing potential must use an effective method of contraception.
排除标准
- 未提供