Pharmacology Study of Aerosolized Liposomal - Full Text View

Sponsored by:	University of New Mexico
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00250120

Purpose

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 II

MedlinePlus related topics: Cancer

Drug Information available for: Camptothecin Rubitecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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 ] [ Designated as safety issue: No ]

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:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250120

Locations

United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator:

Claire F Verschraegen, MD

University of New Mexico

More Information

Responsible Party:	Universtiy of New Mexico - CRTC ( Claire Verschraegen, MD; Principal Investigator )
Study ID Numbers:	1402C-T
Study First Received:	November 3, 2005
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00250120
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of New Mexico:

NSCLC
L9NC
Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin

Study placed in the following topic categories:

Non-small cell lung cancer
Respiratory Tract Diseases
Lung Diseases
9-nitrocamptothecin
Camptothecin

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009