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Pharmacology Study of Aerosolized Liposomal

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00250120
First Posted: November 7, 2005
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of New Mexico
November 3, 2005
November 7, 2005
May 12, 2016
April 2003
March 2007   (Final data collection date for primary outcome measure)
Pathological examination of lung tissure [ Time Frame: at surgery ]
Not Provided
Complete list of historical versions of study NCT00250120 on ClinicalTrials.gov Archive Site
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Pharmacology Study of Aerosolized Liposomal
Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S) - Camptothecin (L9NC)

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Lung Diseases
  • Cancer
Drug: L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin
delivery mode: inhalation
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2007
March 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients participating in INST 1402C protocol
  • Phase II Study of Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC) in Patients with Advanced (NSCLC) Lung Cancer are eligible if their tumor is resectable with curative intent as determined by Dr. Reza Mehran.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00250120
1402C-T
Yes
Not Provided
Not Provided
Claire Verschraegen, MD; Principal Investigator, Universtiy of New Mexico - CRTC
University of New Mexico
Not Provided
Principal Investigator: Claire F Verschraegen, MD University of New Mexico
University of New Mexico
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP