Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087191
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2004-07-08
Brief Title:
EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial is studying the amount of EF5 and motexafin lutetium present in tumor cells andor 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 1-25 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
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 1-25 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UPCC 04204 | None | None | None |
| P01CA087971 | NIH | None | None |
| CDR0000373812 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchP01CA087971 |