The Detection of Tumor Hypoxia and Vascularity in Patients Undergoing Intraperitoneal Photodynamic Therapy
Overview
- Phase
- Not Applicable
- Intervention
- etanidazole
- Conditions
- Advanced Malignant Mesothelioma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Levels of microvascular density by PECAM/CD31 staining
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
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
Detailed Description
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. OUTLINE: This is a multicenter study. 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. Patients are followed at 2 weeks and at 30-45 days post EF5 infusion. PROJECTED ACCRUAL: A total of 80 patients (50 with intraperitoneal malignancy and 30 with pleural malignancy) will be accrued for this study within 2.5 years. Patients are stratified by disease (intraperitoneal malignancy vs pleural malignancy).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: etanidazole
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.
Intervention: therapeutic conventional surgery
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.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Levels of microvascular density by PECAM/CD31 staining
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Not Provided
Relationships among levels of hypoxia, microvascular density, and photosensitizer levels
Time Frame: At the completion of surgery
Secondary Outcomes
- Toxicity of EF5 administration(Up to 45 days after EF5 infusion)