A Phase I Trial of Herceptin and Interleukin-12
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 2.0 (CTCAE v2.0)
研究概览
简要总结
Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of interleukin-12 and trastuzumab in treating patients who have cancer that has high levels of HER2/neu and has not responded to previous therapy
详细描述
OBJECTIVES:
I. Determine the maximum tolerated dose of interleukin-12 (IL-12) when combined with trastuzumab in patients with HER2-Neu overexpressing malignancies.
II. Determine the safety of this regimen in these patients.
III. Analyze any expression of interferon-inducible genes in tumor tissues of these patients after receiving this regimen.
IV. Characterize natural killer cytokine production in patients treated with this regimen.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a histologically proven Her2 overexpressing malignancy as determined by any standardized assay currently in clinical use
- •Patients must have measurable or evaluable disease
- •The patient must have failed standard curative and/or palliative therapies for their disease
- •Life expectancy of at least 6 months
- •No concurrent malignancy other than non-melanoma skin carcinoma
- •Adequate hematopoietic, cardiac, renal, and hepatic function
- •Calculated creatinine clearance will be used to assess renal function
- •Karnofsky Performance Status index >= 70%
- •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; a woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant
- •Normal cardiac ejection fraction by echocardiogram or MUGA (i.e., greater than OSU lower limit of normal)
- •Written signed informed consent; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
排除标准
- •History of significant peripheral neuropathy or significant central nervous system disease
- •Brain or central nervous system metastasis at entry
- •Active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention; history of coronary artery disease or congestive heart failure
- •Pregnant or nursing women
- •Surgery, radiotherapy, chemotherapy, or hormonal therapy during the three weeks prior to the initiation of therapy
- •Exposure to any investigational drug within three weeks prior to the start of dosing
- •Concurrent use of systemic corticosteroids
- •Known seropositive for hepatitis B surface antigen
- •Known seropositive for HIV antibody
- •Serious concurrent infection requiring intravenous antibiotic therapy
- •Clinically significant autoimmune disease (e.g., rheumatoid arthritis)
- •Clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer disease
- •History of inflammatory bowel disease
- •Any other major illness which, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study
- •Prior therapy with Herceptin
结局指标
主要结局
Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 2.0 (CTCAE v2.0)
时间窗: Up to 52 weeks
次要结局
未报告次要终点