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Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S) - Camptothecin (L9NC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Diseases, Cancer

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Trial Information

Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S) - Camptothecin (L9NC)


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological examination of lung tissure

Outcome Time Frame:

at surgery

Safety Issue:

No

Principal Investigator

Claire F Verschraegen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico

Authority:

United States: Food and Drug Administration

Study ID:

1402C-T

NCT ID:

NCT00250120

Start Date:

April 2003

Completion Date:

August 2007

Related Keywords:

  • Lung Diseases
  • Cancer
  • NSCLC
  • L9NC
  • Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin
  • Lung Diseases

Name

Location
University of New Mexico Albuquerque, New Mexico  87131