Cancer, Lung Diseases
Conditions
Keywords
NSCLC, L9NC, Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin
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.
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.
Interventions
DRUGL9NC: Liposomal 9-Nitro-20 (S)-Camptothecin
delivery mode: inhalation
Sponsors
University of New Mexico
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological examination of lung tissure | at surgery |
Countries
United States
Outcome results
None listed