Spots Global Cancer Trial Database for Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
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Trial Identification
Brief Title: Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
Official Title: Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
Study ID: NCT01650090
Conditions
Interventions
Study Description
Brief 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.
Eligibility
Minimum Age: 13 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Stanford University Medical Center, Palo Alto, California, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
University of Chicago, Chicago, Illinois, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
The Children's Hospital at Montefiore, Bronx, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Baylor College of Medicine/Texas Children's Hospital, Houston, Texas, United States
Primary Children's Medical Center, Salt Lake City, Utah, United States
Seattle Children's Hospital, Seattle, Washington, United States
Contact Details
Name: Richard Gorlick, MD
Affiliation: The Children's Hospital at Montefiore
Role: PRINCIPAL_INVESTIGATOR
Name: Forrest H Anthony, MD, PhD
Affiliation: Eleison Pharmaceuticals
Role: STUDY_DIRECTOR
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