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Pharmacology Study of Aerosolized Liposomal

This study has been withdrawn prior to enrollment.
Information provided by:
University of New Mexico Identifier:
First received: November 3, 2005
Last updated: May 10, 2016
Last verified: May 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 Intervention Phase
Lung Diseases Cancer Drug: L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S) - Camptothecin (L9NC)

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Pathological examination of lung tissure [ Time Frame: at surgery ]

Enrollment: 0
Study Start Date: April 2003
Study Completion Date: August 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin
    delivery mode: inhalation
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: 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00250120

United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Principal Investigator: Claire F Verschraegen, MD University of New Mexico
  More Information

Responsible Party: Claire Verschraegen, MD; Principal Investigator, Universtiy of New Mexico - CRTC Identifier: NCT00250120     History of Changes
Other Study ID Numbers: 1402C-T
Study First Received: November 3, 2005
Last Updated: May 10, 2016

Keywords provided by University of New Mexico:
Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017