Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250120
Status:
WITHDRAWN
Last Update Posted:
2016-05-12
First Post:
2005-11-03
Brief Title:
Pharmacology Study of Aerosolized Liposomal
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 S - Camptothecin L9NC
Status:
WITHDRAWN
Status Verified Date:
2016-05
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:
To determine the overall response rate to liposomal 9-Nitro-20 S-Camptothecin L9NC administered by aerosolization in patients with non-small-cell lung cancer any stage
To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive days per week X 8 weeks every 10 weeks
To perform a pharmacology study of L9NC in the plasma and the lungs after aerosolization A specific protocol will be written for this part
To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive days per week X 8 weeks every 10 weeks
To perform a pharmacology study of L9NC in the plasma and the lungs after aerosolization A specific protocol will be written for this part
Detailed Description:
This is a single-arm non-randomized Phase II trial of DLPC-9NC administered by aerosol 5 consecutive days per week for 8 weeks every 10 weeks
Dose 04 mgml of 9-NC in aerosol reservoir for 60 minutes daily dose of 052 mgm2day per day X5 every week X8 weeks then observe for 2 weeks One course 10 weeks
Patients that have a resectable lung cancer will only receive one course of treatment and will be operated on about two weeks after completing the 8-week course
Dose 04 mgml of 9-NC in aerosol reservoir for 60 minutes daily dose of 052 mgm2day per day X5 every week X8 weeks then observe for 2 weeks One course 10 weeks
Patients that have a resectable lung cancer will only receive one course of treatment and will be operated on about two weeks after completing the 8-week course
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