Suspended

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

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What is being tested

EF5

+ motexafin lutetium
+ pharmacological study
Drug
Other
Who is being recruted

Carcinoma, Ovarian Epithelial
+67

+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2004Actual 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.

Official TitleDistribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies 
NCT00087191
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
30 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Carcinoma, Ovarian Epithelial
Urogenital Diseases
Genital Diseases
Adenocarcinoma
Adnexal Diseases
Bile Duct Diseases
Bile Duct Neoplasms
Biliary Tract Diseases
Biliary Tract Neoplasms
Bronchial Neoplasms
Carcinoid Tumor
Carcinoma
Carcinoma, Bronchogenic
Carcinoma, Non-Small-Cell Lung
Colonic Diseases
Colonic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Fallopian Tube Diseases
Fallopian Tube Neoplasms
Female Urogenital Diseases and Pregnancy Complications
Gallbladder Diseases
Gallbladder Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Intestinal Diseases
Intestinal Neoplasms
Leiomyosarcoma
Liver Diseases
Liver Neoplasms
Lung Diseases
Lung Neoplasms
Malignant Carcinoid Syndrome
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Muscle Tissue
Neoplasms, Nerve Tissue
Ovarian Diseases
Ovarian Neoplasms
Pancreatic Diseases
Pancreatic Neoplasms
Pathologic Processes
Rectal Diseases
Rectal Neoplasms
Recurrence
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Sarcoma
Stomach Diseases
Stomach Neoplasms
Thoracic Neoplasms
Urogenital Neoplasms
Colorectal Neoplasms
Neuroectodermal Tumors
Neoplasms, Connective and Soft Tissue
Germinoma
Cholangiocarcinoma
Neuroendocrine Tumors
Disease Attributes
Gastrointestinal Stromal Tumors
Female Urogenital Diseases
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.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.

Given IV

Given IV

Correlative studies
Study Objectives
Primary Objectives

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.

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.

EF5 biding will be quantified.

Will be graded, tabled for each stratum and for the entire study and summarized by frequencies and percentages.

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
Suspended
Abramson Cancer Center of The University of PennsylvaniaPhiladelphia, United StatesSee the location
SuspendedOne Study Center
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