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Recruitment Status : Withdrawn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

Brief Summary:

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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)
Study Start Date : April 2003
Actual Primary Completion Date : March 2007
Actual Study Completion Date : August 2007

Intervention Details:
  • Drug: L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin
    delivery mode: inhalation

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

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 identifier (NCT number): 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

Responsible Party: Claire Verschraegen, MD; Principal Investigator, Universtiy of New Mexico - CRTC Identifier: NCT00250120     History of Changes
Other Study ID Numbers: 1402C-T
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 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