The Detection of Tumor Hypoxia and Vascularity in Patients Undergoing Intraperitoneal Photodynamic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Levels of microvascular density by PECAM/CD31 staining
研究概览
简要总结
This phase II trial is studying how well EF5 works in detecting oxygen level and blood vessels in tumor cells of patients who are undergoing photodynamic therapy for intraperitoneal or pleural cancer. Diagnostic procedures using EF5 to detect oxygen level and blood vessels in tumor cells may help to improve the way photodynamic therapy is given
详细描述
OBJECTIVES:
I. Determine the level of hypoxia through etanidazole derivative EF5 binding in patients with intraperitoneal or pleural malignancies treated with photodynamic therapy.
II. Determine the microvascular density in this patient population. III. Determine the relationships between levels of hypoxia, measures of microvascular density, and photosensitizer levels in this patient population.
IV. Correlate hypoxia and photosensitizer levels with clinical outcome in this patient population.
V. Determine the toxic effects of EF5 in this patient population.
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 intraperitoneal or pleural malignancy
- •Currently enrolled on 1 of 3 photodynamic therapy trials (UPCC-2997, UPCC-4997, or UPCC-05503)
- •Plan to undergo surgery for treatment on one of these protocols
- •Patients with suspected recurrent disease undergoing surgery for diagnosis and debulking allowed if frozen section shows malignant disease
- •No active extra-abdominal metastatic disease and/or intrahepatic involvement secondary to metastatic carcinoma
- •No borderline tumors of low malignant potential
- •No abdominal disease that cannot be debulked to less than 5 mm residual disease in maximal dimension
- •Performance status - ECOG 0-2
- •WBC at least 2,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin less than 1.5 mg/dL
- •No severe liver disease
- •No cirrhosis
- •No grade III or IV elevations in liver function studies
- •Creatinine no greater than upper limit of normal
- •Creatinine clearance at least 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 month after completion of study treatment
- •Weight no more than 130 kg
- •HIV negative
- •Able to tolerate anesthesia or major surgery
- •No grade III or IV peripheral neuropathy
- •No regional enteritis or ulcerative colitis
- •No contraindication for anesthesia or major surgery
- •Prior combination chemotherapy for malignancy allowed
- •No concurrent chemotherapy except for recurrent or persistent disease
- •No concurrent radiotherapy except for recurrent or persistent disease
- •Prior surgery for malignancy allowed
排除标准
- 未提供
研究组 & 干预措施
Diagnostic (etanidazole)
Patients receive etanidazole derivative EF5 IV over 1-2 hours. Approximately 48 hours after EF5 administration, patients with intraperitoneal tumors undergo surgical resection. Patients with pleural tumors undergo surgical resection approximately 24 hours after EF5 administration. Tumors are then analyzed for EF5 binding and microvascular density by immunohistochemistry and fluorescent antibody techniques.
干预措施: etanidazole (Drug)
Diagnostic (etanidazole)
Patients receive etanidazole derivative EF5 IV over 1-2 hours. Approximately 48 hours after EF5 administration, patients with intraperitoneal tumors undergo surgical resection. Patients with pleural tumors undergo surgical resection approximately 24 hours after EF5 administration. Tumors are then analyzed for EF5 binding and microvascular density by immunohistochemistry and fluorescent antibody techniques.
干预措施: therapeutic conventional surgery (Procedure)
Diagnostic (etanidazole)
Patients receive etanidazole derivative EF5 IV over 1-2 hours. Approximately 48 hours after EF5 administration, patients with intraperitoneal tumors undergo surgical resection. Patients with pleural tumors undergo surgical resection approximately 24 hours after EF5 administration. Tumors are then analyzed for EF5 binding and microvascular density by immunohistochemistry and fluorescent antibody techniques.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Levels of microvascular density by PECAM/CD31 staining
时间窗: At the completion of surgery
Distributions of the four EF5 binding variables and MVD will be examined graphically we anticipate that certain variables may have a Poisson distribution.
Level of hypoxia in tumor nodules
时间窗: At the completion of surgery
Exploratory techniques will be used to describe patterns of EF5 binding as well as MVD within and among patients.
Inter- and intra-patient variability of hypoxia by EF5 binding
时间窗: At the completion of surgery
Inter- and intra-subject variability can be estimated using summary statistics (standard deviations, or the range of data).
Associations between hypoxia and photosensitizer levels in tumor nodules with clinical outcome periodically until disease recurrence
时间窗: Not Provided
Relationships among levels of hypoxia, microvascular density, and photosensitizer levels
时间窗: At the completion of surgery
次要结局
- Toxicity of EF5 administration(Up to 45 days after EF5 infusion)