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.
Pulmonary Relapse of Osteosarcoma
Drug: Inhaled Lipid Cisplatin (ILC)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma|
- Observed Relapse Free Interval (RFI) [ Time Frame: At relapse, estimated at 6-12 months average. ] [ Designated as safety issue: No ]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.
- Median, 1, 2 and 5 year Overall Survival (OS) [ Time Frame: 1, 2 and 5 Years ] [ Designated as safety issue: No ]The percentage of patients alive at 1, 2 and 5 years and the median overall survival.
- Median, 1, 2 and 5 year Event Free Survival (EFS) [ Time Frame: 1, 2 and 5 years ] [ Designated as safety issue: No ]The percentage of patients surviving without disease relapse at 1, 2 and 5 years and the median event free survival.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Inhaled Lipid Cisplatin (ILC) will be administered every two weeks via nebulization and inhalation.
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.
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.
|Contact: Eleison Pharmaceuticalsfirstname.lastname@example.org|
|United States, Florida|
|H. Lee Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Damon Reed, MD 813-745-4292 Damon.Reed@moffitt.org|
|Contact: Courtney Yates, RN (813) 745-4292 Courtney.Yates@moffitt.org|
|Principal Investigator: Damon Reed, MD|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Alex Chou, MD 212-639-6057 email@example.com|
|Contact: Judy Persaud-Moore, MPH 646-888-5722 firstname.lastname@example.org|
|Principal Investigator: Alex Chou, MD|
|Sub-Investigator: Paul Meyers, MD|
|The Children's Hospital at Montefiore||Recruiting|
|The Bronx, New York, United States, 10467|
|Contact: Richard Gorlick, MD 718-741-2342 email@example.com|
|Contact: Jonathan Gill, MD 718-741-2342 firstname.lastname@example.org|
|Principal Investigator: Richard Gorlick, MD|
|Sub-Investigator: Jonathan Gill, MD|
|Principal Investigator:||Richard Gorlick, MD||The Children's Hospital at Montefiore|
|Study Director:||Forrest H Anthony, MD, PhD||Eleison Pharmaceuticals|