Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Motexafin lutetium uptake in tumors and normal tissues
研究概览
简要总结
This clinical trial is studying the amount of EF5 and motexafin lutetium present in tumor cells and/or normal tissues of patients with abdominal (such as ovarian, colon, or stomach cancer) or non-small cell lung cancer. EF5 may be effective in measuring oxygen in tumor tissue. Photosensitizing drugs such as motexafin lutetium are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. Knowing the level of oxygen in tumor tissue and the level of motexafin lutetium absorbed by tumors and normal tissue may help predict the effectiveness of anticancer therapy
详细描述
OBJECTIVES:
I. Determine the uptake of motexafin lutetium in tumors and normal tissue of patients with intra-abdominal malignancies or non-small cell lung cancer.
II. Determine the ratio of tumor to normal tissue by measuring the level of motexafin lutetium uptake in tumor and normal tissue removed from these patients.
III. Determine the pattern, presence, and level of EF5 binding (as a surrogate marker for hypoxia) in tumors of these patients.
IV. Determine the feasibility of measuring optical properties, tissue oxygenation, motexafin lutetium concentration, fluorescence, and blood flow by non-invasive means in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Histologically confirmed or suspected diagnosis of 1 of the following:
- •Intra-abdominal malignancy of 1 of the following types:
- •Ovarian cancer
- •Gastrointestinal malignancies, including, but not limited to, appendiceal cancer, colon cancer, or gastric cancer
- •Non-small cell lung cancer
- •Planning to undergo surgical resection of disease
- •Disease has the propensity to spread to the peritoneal cavity (intra-abdominal malignancy patients)
- •Performance status - ECOG 0-2
- •WBC ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin < 1.5 mg/dL
- •Creatinine normal
- •Creatinine clearance ≥ 60 mL/min
- •Body weight ≤ 130 kg
- •No G6PD deficiency
- •No porphyria
- •No history of peripheral neuropathy ≥ grade 3
- •Able to tolerate anesthesia and major surgery
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 month after study participation
排除标准
- 未提供
研究组 & 干预措施
Diagnostic (EF5, motexafin lutetium)
Patients receive EF5 IV over 1-2.5 hours on day 1 and motexafin lutetium IV over 10-15 minutes on day 2. Patients undergo definitive surgical resection approximately 3 hours after motexafin lutetium administration. Hypoxia and motexafin lutetium levels in the resected tumors are evaluated. Tumor to normal tissue ratios are also determined.
干预措施: EF5 (Drug)
Diagnostic (EF5, motexafin lutetium)
Patients receive EF5 IV over 1-2.5 hours on day 1 and motexafin lutetium IV over 10-15 minutes on day 2. Patients undergo definitive surgical resection approximately 3 hours after motexafin lutetium administration. Hypoxia and motexafin lutetium levels in the resected tumors are evaluated. Tumor to normal tissue ratios are also determined.
干预措施: motexafin lutetium (Drug)
Diagnostic (EF5, motexafin lutetium)
Patients receive EF5 IV over 1-2.5 hours on day 1 and motexafin lutetium IV over 10-15 minutes on day 2. Patients undergo definitive surgical resection approximately 3 hours after motexafin lutetium administration. Hypoxia and motexafin lutetium levels in the resected tumors are evaluated. Tumor to normal tissue ratios are also determined.
干预措施: pharmacological study (Other)
结局指标
主要结局
Motexafin lutetium uptake in tumors and normal tissues
时间窗: At the time of surgery
Data will be described using graphical techniques (e.g., box plots) and summary statistics (e.g., means, medians, standard deviations, and interquartile ranges). For each patient, the mean concentration of motexafin lutetium across tumor and normal samples will be summarized.
Tumor to normal tissue ration (TNTR) of motexafin lutetium for any tumor and normal tissue
时间窗: At the time of surgery
Summary data for each patient will be used to construct a TNTR. Wilcoxon signed rank test of whether the median ration exceeds will be carried out.
Pattern and presence of EF5 binding
时间窗: At the time of surgery
EF5 biding will be quantified.
Toxicity as assessed by NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
时间窗: Up to 60 days following EF5 infusion
Will be graded, tabled for each stratum and for the entire study and summarized by frequencies and percentages.
次要结局
未报告次要终点