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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin | Drug | delivery mode: inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological examination of lung tissure | at surgery |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire F Verschraegen, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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