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Pharmacology Study of Aerosolized Liposomal

This study has been completed.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00250120
First received: November 3, 2005
Last updated: January 6, 2010
Last verified: October 2008

November 3, 2005
January 6, 2010
April 2003
March 2007   (final data collection date for primary outcome measure)
Pathological examination of lung tissure [ Time Frame: at surgery ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00250120
1402C-T
Yes
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
October 2008

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