Advanced Adult Primary Liver CancerNCT00087191
EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
A study testing EF5, motexafin lutetium and pharmacological study in people with Advanced Adult Primary Liver Cancer and Carcinoma of the Appendix, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix, Fallopian Tube Cancer
- What is being tested?
- EF5, motexafin lutetium and pharmacological study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 22Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies
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
Read the detailed description
OBJECTIVES:
- 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.
- Conditions
- Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix, Fallopian Tube Cancer, Gastrointestinal Stromal Tumor, Localized Extrahepatic Bile Duct Cancer, Localized Gallbladder Cancer
- Being tested
- EF5, motexafin lutetium, pharmacological study
- Medical subject headings
- Appendiceal Neoplasms, Fallopian Tube Neoplasms, Gastrointestinal Stromal Tumors, Carcinoma, Hepatocellular, Sarcoma, Colonic Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EF5Drug
Given IV
motexafin lutetiumDrug
Also called Antrin, lutetium texaphrin, lutetium texaphyrin, Lutex
Given IV
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: EF5; Drug: motexafin lutetium; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the time of surgery
Pattern and presence of EF5 binding
EF5 biding will be quantified.
Measured: 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.
Measured: Up to 60 days following EF5 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2004 (estimated)
- Study startMay 2004
- Primary completionJan 2006
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Adult Primary Liver CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephen Michael Hahn, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087191
- Sponsor's protocol ID
- NCI-2012-02607
- Other IDs
- UPCC# 04204, P01CA087971, CDR0000373812
- Status last verified
- Jan 2013
- First submitted
- 8 Jul 2004
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies
- ClinicalTrials.gov ID
- NCT00087191
- Acronym / sponsor ID
- NCI-2012-02607
- Conditions
- Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix, Fallopian Tube Cancer, Gastrointestinal Stromal Tumor, Localized Extrahepatic Bile Duct Cancer, Localized Gallbladder Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2004
- Primary completion
- Jan 2006 (actual)
- First posted
- 12 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (EF5, motexafin lutetium) | Experimental | Drug: EF5, Drug: motexafin lutetium, Other: pharmacological studyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically confirmed or suspected diagnosis of 1 of the following:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EF5Given IV | Drug | Diagnostic (EF5, motexafin lutetium) |
| motexafin lutetiumAlso: Antrin, lutetium texaphrin, lutetium texaphyrin, LutexGiven IV | Drug | Diagnostic (EF5, motexafin lutetium) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Diagnostic (EF5, motexafin lutetium) |
Primary outcome
Motexafin lutetium uptake in tumors and normal tissues
Time frame: 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.
Tumor to normal tissue ration (TNTR) of motexafin lutetium for any tumor and normal tissue
Time frame: 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.
Pattern and presence of EF5 binding
Time frame: 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
Time frame: 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.
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
Related trials for Advanced Adult Primary Liver Cancer
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
Active, not recruitingPhase 2
TSR-022 (Anti-TIM-3 Antibody) and TSR-042 (Anti-PD-1 Antibody) in Patients With Liver Cancer
Adult Primary Liver Cancer, Advanced Adult Primary Liver Cancer
RecruitingPhase 1
PIN in Combination With Anti-PD1 in Previously Treated Primary Hepatocellular Carcinoma
Hepatocellular Carcinoma, Adult
Active, not recruitingObservational study
Pilot Study to Assess Lung Shunting of Yttrium-90 Microspheres Using PET/CT
Advanced Adult Primary Liver Cancer, Liver Metastases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Michael Hahn principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EF5, motexafin lutetium and pharmacological study in people with Advanced Adult Primary Liver Cancer and Carcinoma of the Appendix, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motexafin lutetium uptake in tumors and normal tissues (time frame: At the time of surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.