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| ID | Type | Description | Link |
|---|---|---|---|
| UPCC# 04204 | |||
| P01CA087971 | U.S. NIH Grant/Contract | View source | |
| CDR0000373812 | Registry Identifier | PDQ (Physician Data Query) |
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Administratively complete.
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (EF5, motexafin lutetium) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EF5 | Drug | Given IV |
| |
| motexafin lutetium |
| Measure | Description | Time Frame |
|---|---|---|
| Motexafin lutetium uptake in tumors and normal tissues | 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. | At the time of surgery |
| Tumor to normal tissue ration (TNTR) of motexafin lutetium for any tumor and normal tissue | 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. | At the time of surgery |
| Pattern and presence of EF5 binding | EF5 biding will be quantified. | At the time of surgery |
| Toxicity as assessed by NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 | Will be graded, tabled for each stratum and for the entire study and summarized by frequencies and percentages. | Up to 60 days following EF5 infusion |
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Inclusion Criteria:
Histologically confirmed or suspected diagnosis of 1 of the following:
Intra-abdominal malignancy of 1 of the following types:
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
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Michael Hahn | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| Drug |
Given IV |
|
|
| pharmacological study | Other | Correlative studies |
|
|
| ID | Term |
|---|---|
| D001063 | Appendiceal Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D046152 | Gastrointestinal Stromal Tumors |
| D006528 | Carcinoma, Hepatocellular |
| D012509 | Sarcoma |
| D003110 | Colonic Neoplasms |
| D001650 | Bile Duct Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D013274 | Stomach Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D010190 | Pancreatic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D002430 | Cecal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D015179 | Colorectal Neoplasms |
| D003108 | Colonic Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
| D013272 | Stomach Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D010182 | Pancreatic Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C102825 | motexafin lutetium |
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