Pharmacology Study of Aerosolized Liposomal

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. Identifier: NCT00250120
Recruitment Status : Withdrawn
First Posted : November 7, 2005
Last Update Posted : May 12, 2016
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 ]
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Complete list of historical versions of study NCT00250120 on 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.

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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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)
Contact information is only displayed when the study is recruiting subjects
United States
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Claire Verschraegen, MD; Principal Investigator, Universtiy of New Mexico - CRTC
University of New Mexico
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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