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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
28
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.
Children's Hospital Los Angeles
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
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.
Time frame: At relapse, estimated at 6-12 months average.
Median, 1, 2 and 5 year Overall Survival (OS)
The percentage of patients alive at 1, 2 and 5 years and the median overall survival.
Time frame: 1, 2 and 5 Years
Median, 1, 2 and 5 year Event Free Survival (EFS)
The percentage of patients surviving without disease relapse at 1, 2 and 5 years and the median event free survival.
Time frame: 1, 2 and 5 years
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H. Lee Moffitt Cancer Center
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University of Chicago
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Ochsner Clinic Foundation
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
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Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
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The Children's Hospital at Montefiore
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...and 5 more locations