Spots Global Cancer Trial Database for Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)

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Trial Identification

Brief Title: Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)

Official Title: Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)

Study ID: NCT00250068

Conditions

Lung Diseases

Cancer

Interventions

Liposomal 9-Nitrocamptothecin

Study Description

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.