Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies
EF5
+ motexafin lutetium
+ pharmacological study
Carcinoma, Ovarian Epithelial+67
+ Urogenital Diseases
+ Genital Diseases
Diagnostic Study
Summary
Study start date: May 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location