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.
Checked against the public recordLast updated Aug 7, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Eleison Pharmaceuticals LLC.
- Interventions being studied
- Drug: Inhaled Lipid Cisplatin (ILC)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. History of osteosarcoma metastatic to the lung(s). (First or second pulmonary recurrence(s) removed by surgery, and previous second-line systemic chemotherapy is allowed). 2. Patients must be macroscopically disease free following pulmonary metastectomy of a single or multiple lesions. Complete remission surgically (free of macroscopic disease) is required. Pleural disruption and/or microscopic positive margins are allowed. 3. Age ≥13 years. 4. Patients must have recovered sufficiently from all acute adverse effects of prior therapies, excluding alopecia. 5. Patients must have an ECOG performance status of 0-2. (Lansky score of 50-100 if \< 16 years old). 6. Patients must have recovered sufficiently from surgery and have adequate airflow and pulmonary reserve. This decision should be at the investigator's discretion taking into consideration pre-surgery pulmonary function. (As a guideline: adequate airflow defined by a measured Forced Expiratory Volume (FEV1) not less than 50% of the predicted value and adequate pulmonary reserve as evidenced by a FEV1/FVC ratio of 65% or greater). 7. Patients must have adequate renal function as defined by a serum creatinine of ≤ 1.5 mg/dl. 8. Patients must have adequate liver function as defined by total bilirubin of ≤ 1.5 mg/dl and ALT or AST \< 2.5 times the institution's upper normal limit. 9. Patients must have adequate bone marrow function as defined by an absolute neutrophil count (ANC) of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3. 10. Signed informed consent including, where applicable, the consent of the patient's legal guardian. Exclusion Criteria: 1. Current extrapulmonary disease. 2. Current macroscopic pulmonary lesions. 3. Greater than 2 pulmonary recurrences. 4. Greater than 4 weeks since thoracotomy rendering patient free of macroscopic disease. 5. Females who are pregnant or breast-feeding. 6. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study. 7. Contraindication to or unwillingness to undergo multiple CT scans and chest X-rays. 8. Unwillingness or inability to comply with the study protocol for any other reason. 9. Participation in an investigational drug or device study or treatment with any anti-neoplastic agent within 14 days of the first day of dosing on this study
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Children's Hospital Los AngelesLos Angeles, California
- Stanford University Medical CenterPalo Alto, California
- H. Lee Moffitt Cancer CenterTampa, Florida
- University of ChicagoChicago, Illinois
- Ochsner Clinic FoundationNew Orleans, Louisiana
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Mayo ClinicRochester, Minnesota
- Washington University School of MedicineSt Louis, Missouri
- Memorial Sloan-Kettering Cancer CenterNew York, New York
- The Children's Hospital at MontefioreThe Bronx, New York
- Vanderbilt-Ingram Cancer CenterNashville, Tennessee
- UT Southwestern Medical CenterDallas, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 7, 2019. Always confirm current availability with the study team.