Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003282
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
1999-11-01
Brief Title:
EF5 in Treating Patients With Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of EF5 an Agent for the Detection of Hypoxia
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors This phase I trial is studying how well EF5 works in detecting the presence of oxygen in tumor cells in patients with solid tumors that can be biopsied or removed by surgery
Detailed Description:
PRIMARY OBJECTIVES
I Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal signal-to-noise ratio in patients with solid tumors
II Determine the toxic effects of EF5 in this patient population III Determine the pharmacokinetics of EF5 in this patient population IV Determine the dose of EF5 that provides a mean signal-to-noise ratio maximum binding in anoxia to minimum binding of 75
V Determine the relationship between tumor oxygenation by EF5 binding and needle electrode measurements
VI Compare the levels of EF5 binding in regions of low and high blood flow
OUTLINE This is a dose-escalation study
Patients receive etanidazole derivative EF5 IV over 1-2 hours beginning approximately 24 hours prior to surgery Tumors are then resected or biopsied after Eppendorf needle electrode measurements
Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose MTD or optimal dose is determined The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity The optimal dose is defined as the dose level at or below the MTD and results in a signal-to-noise ratio of 75 or greater Thirty additional patients are treated at the optimal dose
Patients are followed at 30-45 days post EF5 infusion
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
I Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal signal-to-noise ratio in patients with solid tumors
II Determine the toxic effects of EF5 in this patient population III Determine the pharmacokinetics of EF5 in this patient population IV Determine the dose of EF5 that provides a mean signal-to-noise ratio maximum binding in anoxia to minimum binding of 75
V Determine the relationship between tumor oxygenation by EF5 binding and needle electrode measurements
VI Compare the levels of EF5 binding in regions of low and high blood flow
OUTLINE This is a dose-escalation study
Patients receive etanidazole derivative EF5 IV over 1-2 hours beginning approximately 24 hours prior to surgery Tumors are then resected or biopsied after Eppendorf needle electrode measurements
Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose MTD or optimal dose is determined The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity The optimal dose is defined as the dose level at or below the MTD and results in a signal-to-noise ratio of 75 or greater Thirty additional patients are treated at the optimal dose
Patients are followed at 30-45 days post EF5 infusion
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 7597 | None | None | None |
| R01CA075285 | NIH | None | None |
| CDR0000066191 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchR01CA075285 |