EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer

Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies

Sponsors

Lead Sponsor: National Cancer Institute (NCI)

Source 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.

Overall Status Terminated
Start Date May 2004
Primary Completion Date January 2006
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Motexafin lutetium uptake in tumors and normal tissues At the time of surgery
Tumor to normal tissue ration (TNTR) of motexafin lutetium for any tumor and normal tissue At the time of surgery
Pattern and presence of EF5 binding At the time of surgery
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
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: EF5

Description: Given IV

Arm Group Label: Diagnostic (EF5, motexafin lutetium)

Intervention Type: Drug

Intervention Name: motexafin lutetium

Description: Given IV

Arm Group Label: Diagnostic (EF5, motexafin lutetium)

Intervention Type: Other

Intervention Name: pharmacological study

Description: Correlative studies

Arm Group Label: Diagnostic (EF5, motexafin lutetium)

Other Name: pharmacological studies

Eligibility

Criteria:

Inclusion Criteria: - 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 - 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Stephen Michael Hahn Principal Investigator Abramson Cancer Center of the University of Pennsylvania
Location
Facility: Abramson Cancer Center of The University of Pennsylvania
Location Countries

United States

Verification Date

January 2013

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Diagnostic (EF5, motexafin lutetium)

Type: Experimental

Description: 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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov