Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
ILC is a novel formulation of cisplatin, designed for inhalation by nebulization. The
anticipated pulmonary benefits of ILC over systemic cisplatin therapy are threefold:
- Increased local cisplatin concentrations
- Sustained release of cisplatin in the lungs
- Minimal systemic exposure to cisplatin
In this study, patients currently in surgical complete remission (CR) following one or two
prior relapses of osteosarcoma involving pulmonary disease will be treated with ILC every
two weeks for up to one year. ILC will be administered via nebulization.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Observed Relapse Free Interval (RFI)
Observed relapse free interval (RFI) will be compared to historical controls. Relapse free interval is defined as the time of diagnosis of the previous relapse to time of diagnosis of the new relapse.
At relapse, estimated at 6-12 months average.
Richard Gorlick, MD
The Children's Hospital at Montefiore
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|H. Lee Moffitt Cancer Center||Tampa, Florida 33612|
|University of Chicago||Chicago, Illinois 60637|
|The Children's Hospital at Montefiore||The Bronx, New York 10467|