NCT00012155已完成1 期
A Phase I, Open-Label, Dose-Escalating Study Of The Safety, Tolerability, And Anti-Tumor Activity Of A Single Intrahepatic Arterial Injection Of Genetically Engineered Herpes Simplex Virus, NV1020, In Subjects With Adenocarcinoma Of The Colon With Metastasis To The Liver
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the safety of NV1020 in patients who have colon cancer that has spread to the liver and has not responded to previous chemotherapy.
详细描述
OBJECTIVES:
- Determine the safety and maximum tolerated dose of a single intrahepatic NV1020 injection in patients with hepatic metastases from colon cancer that has failed first-line chemotherapy.
- Determine the tolerability of this drug in these patients.
- Determine preliminarily the anti-tumor activity of this drug in these patients.
- Assess the immunogenicity of NV1020 in these patients.
OUTLINE: This is a dose escalation study.
Patients receive a single intrahepatic arterial injection of NV1020 over 10 minutes with the aid of hepatic arteriography.
Cohorts of 3 patients receive escalating doses of NV1020 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 adenocarcinoma of the colon
- •At least 3 metastatic hepatic lesions involving both lobes
- •No extrahepatic disease
- •Failed first-line combination chemotherapy of fluorouracil plus either leucovorin calcium or irinotecan
- •Herpes simplex virus type-1 seropositive
- •Candidate for intrahepatic arterial infusion pump placement
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 9.0 g/dL
- •No history of any blood clotting disorder (e.g., hemophilia)
- •Transaminases no greater than 3 times upper limit of normal
- •Bilirubin no greater than 2.0 mg/dL
- •No active hepatitis
- •No history of hepatic fibrosis, cirrhosis, or hemochromatosis
- •Creatinine no greater than 2.0 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •All patients must use effective barrier contraception during and for at least 6 months after study
- •HIV negative
- •No active herpes infection
- •No other active uncontrolled infection
- •No prior weight loss of more than 10 lbs within the past month
- •No history of alcohol or other substance abuse
- •No concurrent unstable and/or severe medical or psychological condition
- •No history of any other medical or psychological condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy (e.g., interleukin-2, interleukin -12, or interferon)
- •No prior gene transfer therapy
- •No prior therapy with cytolytic virus of any type
- •No concurrent immunotherapy during and for 28 days after study therapy
- •No concurrent vaccines during and for 28 days after study therapy
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •No concurrent chemotherapy during and for 28 days after study therapy
- •Endocrine therapy:
- •No concurrent systemic steroids during and for 28 days after study therapy
- •Radiotherapy:
- •No prior radiotherapy to the liver
- •No concurrent radiotherapy during and for 28 days after study therapy
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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