NCT00250068

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Diseases
• Cancer

Interventions

Type	Name	Description
DRUG	Liposomal 9-Nitrocamptothecin	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

Timeline

• Start date: 2003-04-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-11-07
• Last updated: 2010-05-19

Locations

1 site across 1 country: United States