Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities
研究概览
简要总结
Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have recurrent or persistent metastatic colorectal cancer. Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Radiolabeled monoclonal antibody therapy may be effective treatment for colorectal cancer
详细描述
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of iodine I 131 monoclonal antibody CC49-deltaCH2 (deleted CH2 region) in patients with colorectal cancer.
II. Determine the toxic effects, plasma pharmacokinetics, whole body biodistribution, and conjugate stability of this drug in these patients.
III. Determine the ability of this drug to localize to tumor sites in these patients.
IV. Determine the immune response in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic adenocarcinoma of the colon or rectum
- •Not amenable to surgical resection
- •Recurrent or persistent disease after standard surgery, radiotherapy, and chemotherapy, including fluorouracil and irinotecan
- •TAG-72 positive
- •Performance status - ECOG 0-2
- •WBC greater than 3,500/mm^3
- •Platelet count greater than 125,000/mm^3
- •Hemoglobin greater than 10 g/dL
- •No nucleated RBC or significant teardrop RBC morphology
- •Bilirubin less than 1.5 mg/dL
- •SGOT/SGPT less than 4 times normal
- •Hepatitis B surface antigen negative
- •Creatinine less than 2.0 mg/dL
- •HIV negative
- •No other malignancy within the past 5 years except basal cell skin cancer
- •No allergy to iodine
- •No detectable antibody to monoclonal antibody CC49
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •At least 3 weeks since prior immunotherapy and recovered
- •No prior bone marrow or stem cell transplantation
- •No other concurrent immunotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy and recovered
- •No concurrent chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to more than 25% of red marrow
- •No concurrent radiotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior surgery and recovered
排除标准
- 未提供
研究组 & 干预措施
Treatment (monoclonal antibody)
Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1 and a therapy dose over 30 minutes on day 8.
Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49-deltaCH2 until the MTD is determined. The MTD is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity.
干预措施: iodine I 131 monoclonal antibody CC49-deltaCH2 (Drug)
结局指标
主要结局
Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities
时间窗: 6 weeks
次要结局
- Immune response(Up to 54 weeks)