A Phase I / Pilot Study of Intra-Arterial Supradose Cisplatin With Simultaneous Intravenous Thiosulfate Neutralization in Patients With Primary Lung Cancer or Lung Metastases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Frequency of adverse events due to intra-arterial cisplatin administration
研究概览
简要总结
This phase I study proposes the use of systemic thiosulfate rescue to allow supradose intra-arterial cisplatin delivery to lung tumors. Eligible patients would be those with at least one lung lesion large enough of characterize angiographically. All patients will first undergo a CT arteriogram of the target tumor. Patients will then receive 2 treatments on 2 consecutive weeks. The primary endpoint will be toxicity, with secondary endpoint of response as measured on week 4. This pilot study will also determine how technically feasible it is to locate the blood supply to these tumors and deliver cisplatin.
If the first 6 patients do well, 6 additional patients will be accrued for a total of 12.
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
- •Primary lung cancer (any type) or dominant lung metastases from other primary cancers.
- •Patients must have either measurable or evaluable disease.
- •Karnofsky performance status ≥ 70%.
- •Greater than 18 years of age.
- •Life expectancy > 3 months.
- •3 week elapse from previous cytotoxic therapy (except for erlotinib or hormonal therapy, which can be ongoing) with side effects improved to grade 2 or less, and no prior radiotherapy to the lung.
- •Adequate organ function.
- •Treated brain metastases, if present, with toxicities improved to grade 2 or less.
- •Willingness and ability to sign a written informed consent.
排除标准
- •Prior radiation to the largest lesion in the lung.
- •Current pregnancy or breast-feeding.
- •Unwillingness or inability to practice contraception.
- •Renal insufficiency.
- •Comorbidities of grade 3 or greater.
- •Concurrent medical or psychiatric conditions as defined by the treating physician which would preclude safe performance of study procedures or compromise the ability of the patient to consent to study.
研究组 & 干预措施
IA Cisplatin / IV Thiosulfate
Single-arm study
干预措施: Cisplatin, Thiosulfate (Drug)
结局指标
主要结局
Frequency of adverse events due to intra-arterial cisplatin administration
时间窗: One week after treatment
To characterize the toxicity of intra-arterial supradose cisplatin with thiosulfate rescue when delivered as two doses, one week apart, for patients with primary lung tumors and/or lung metastases.
次要结局
- Radiographic determination of the tumor response rate in patients with primary and metastatic lung tumors treated with intra-arterial supradose cisplatin.(4 weeks after first dose of cisplatin)
- Angiographic delineation of the vascular structure of primary lung tumors and lung metastases.(Once before treatment)
研究者
Gregory Daniels
Professor
University of California, San Diego