Pharmacology Study of Aerosolized Liposomal
|ClinicalTrials.gov Identifier: NCT00250120|
Recruitment Status : Withdrawn
First Posted : November 7, 2005
Last Update Posted : May 12, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Diseases Cancer||Drug: L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin||Phase 2|
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: 0.4 mg/ml of 9-NC in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day) 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S) - Camptothecin (L9NC)|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||August 2007|
- Drug: L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin
delivery mode: inhalation
- Pathological examination of lung tissure [ Time Frame: at surgery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250120
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Claire F Verschraegen, MD||University of New Mexico|