Pulmonary Relapse of Osteosarcoma Clinical Trial
Official title:
Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical remission following one or two prior pulmonary relapses.
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.
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