Pharmacology Study of Aerosolized Liposomal
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|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Recruitment Status : Withdrawn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
- Pathological examination of lung tissure [ Time Frame: at surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|