EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
- Conditions
- Localized Extrahepatic Bile Duct CancerLocalized Gastrointestinal Carcinoid TumorLocalized Resectable Adult Primary Liver CancerAdvanced Adult Primary Liver CancerSmall Intestine LymphomaLocalized Unresectable Adult Primary Liver CancerOvarian SarcomaOvarian Stromal CancerCarcinoma of the AppendixFallopian Tube Cancer
- Interventions
- Registration Number
- NCT00087191
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
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
- Detailed Description
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.
OUTLINE: This is a multicenter, diagnostic study. Patients are stratified according to diagnosis (intra-abdominal malignancy vs non-small cell lung cancer).
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.
After completion of study treatment, patients are followed at approximately 1-8 weeks.
PROJECTED ACCRUAL: A total of 30 patients (20 with intra-abdominal malignancies and 10 with non-small cell lung cancer) will be accrued for this study within 10-15 months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
-
Histologically confirmed or suspected diagnosis of 1 of the following:
-
Intra-abdominal malignancy of 1 of the following types:
- Sarcoma
- 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
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Disease has the propensity to spread to the peritoneal cavity (intra-abdominal malignancy patients)
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Performance status - ECOG 0-2
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WBC ≥ 2,000/mm^3
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Platelet count ≥ 100,000/mm^3
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Bilirubin < 1.5 mg/dL
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Creatinine normal
-
Creatinine clearance ≥ 60 mL/min
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Body weight ≤ 130 kg
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No G6PD deficiency
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No porphyria
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No history of peripheral neuropathy ≥ grade 3
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Able to tolerate anesthesia and major surgery
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Not pregnant or nursing
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Negative pregnancy test
-
Fertile patients must use effective contraception during and for 1 month after study participation
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic (EF5, motexafin lutetium) pharmacological study 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. Diagnostic (EF5, motexafin lutetium) EF5 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. Diagnostic (EF5, motexafin lutetium) 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.
- Primary Outcome Measures
Name Time Method Tumor to normal tissue ration (TNTR) of motexafin lutetium for any tumor and normal tissue 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.
Motexafin lutetium uptake in tumors and normal tissues 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.
Pattern and presence of EF5 binding 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Abramson Cancer Center of The University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States