Phase I Study of MOC31-PE in Antigen Positive Carcinomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The documentation of the Maximum Tolerated Dose (MID)
研究概览
简要总结
Immunotoxins (ITs), monoclonal antibodies conjugated to plant or bacterial toxins, have been extensively investigated for their possible use as anti-tumor agents although not in carcinoma patients with minimal residual disease. Various ITs have been tested in early clinical trials and recent studies demonstrate anti-tumor activity of IT treatment in patients with glioblastoma and different solid tumors. Systemic treatment with immunotoxins directed against carefully selected epithelial cell surface molecules may have a potential for eradicating also dormant metastatic tumor cells, as their action is independent of cell proliferation. The effector moieties of the IT used here, the Pseudomonas exotoxin A (PE), inhibits protein synthesis in eukaryotic cells by catalytic inactivation (ribosylation) of elongation factor 2 in the ribosome complex.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirm epithelial carcinoma, verified to be positive for the targeting antigen(Ep-CAM/epithelial glyco protein 2)according to the criteria given below.
- •Tumor specimens verified to be positive for the targeting antibody,i.e.EGP2 positive (MOC31) by immunocytochemical or histochemical staining.
- •Signed written informed consent
- •Patients with no clinically symptomatic central nervous system (CNS) involvement.
- •Both gender, age 18 -75 years old.
- •Life expectancy of at least 3 months
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- •Adequate hematologic, renal and hepatic function defined as: Neutrophils > 1.5 x 10^9/L;Platelets > 100 x 10^9/L; Creatinine < 120 umol/L; Total bilirubin within normal range. Liver enzymes (ALAT and ASAT <2.5 UNL: alkaline phosphatase < 1.5 UNL and yGT < 1.5 UNL).
- •Coagulation parameters (pT, PTT) within normal range.
排除标准
- •No medical history of Hepatitis B or C infection
- •Patients must have no ECG abnormalities
- •Patients must not be HIV positive
- •Female premenopausal patients should not be pregnant (must have a negative pregnancy test prior to inclusion) and should not be lactating.
- •Patients must use effective contraception if of reproductive potential.
- •Prior chemotherapy and/or radiation should be completed for at least 4 weeks prior to study enrolment
研究组 & 干预措施
MOC31-PE
干预措施: MOC31-PE (Drug)
结局指标
主要结局
The documentation of the Maximum Tolerated Dose (MID)
时间窗: 2 years
The identification of the dose limiting toxicity (DLT)
时间窗: 2 years
次要结局
未报告次要终点
研究者
Svein Dueland
Senior Physician
Oslo University Hospital