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
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S) - Camptothecin (L9NC)

Resource links provided by NLM:


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:
    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.

  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
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, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Claire Verschraegen, MD; Principal Investigator, Universtiy of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00250120     History of Changes
Other Study ID Numbers: 1402C-T
Study First Received: November 3, 2005
Last Updated: January 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of New Mexico:
NSCLC
L9NC
Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lung Diseases
Respiratory Tract Diseases
Camptothecin
9-nitrocamptothecin
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 22, 2014