NCT01650090

Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Eleison Pharmaceuticals LLC. · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pulmonary Relapse of Osteosarcoma

Interventions

Type	Name	Description
DRUG	Inhaled Lipid Cisplatin (ILC)	ILC is provided as cisplatin in a lipid complex suspended in a saline solution. Every two weeks, the patient will receive 36 mg/m2 (measured as concentration of cisplatin) of ILC via nebulization. Treatment may continue for up to 1 year.

Timeline

• Start date: 2012-08-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2012-07-26
• Last updated: 2019-08-07

Locations

15 sites across 1 country: United States