Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
This trial is active, not recruiting.
|Condition||pulmonary relapse of osteosarcoma|
|Treatment||inhaled lipid cisplatin (ilc)|
|Sponsor||Eleison Pharmaceuticals LLC.|
|Start date||August 2012|
|End date||June 2016|
|Trial size||50 participants|
|Trial identifier||NCT01650090, EP-ILC-201|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Los Angeles, CA||Children's Hospital Los Angeles||no longer recruiting|
|Palo Alto, CA||Stanford University Medical Center||no longer recruiting|
|Tampa, FL||H. Lee Moffitt Cancer Center||no longer recruiting|
|Chicago, IL||University of Chicago||no longer recruiting|
|New Orleans, LA||Ochsner Clinic Foundation||no longer recruiting|
|Boston, MA||Dana-Farber Cancer Institute||no longer recruiting|
|Rochester, MN||Mayo Clinic||no longer recruiting|
|St. Louis, MO||Washington University School of Medicine||no longer recruiting|
|New York, NY||Memorial Sloan-Kettering Cancer Center||no longer recruiting|
|The Bronx, NY||The Children's Hospital at Montefiore||no longer recruiting|
|Nashville, TN||Vanderbilt-Ingram Cancer Center||no longer recruiting|
|Dallas, TX||UT Southwestern Medical Center||no longer recruiting|
|Houston, TX||Baylor College of Medicine/Texas Children's Hospital||no longer recruiting|
|Salt Lake City, UT||Primary Children's Medical Center||no longer recruiting|
|Seattle, WA||Seattle Children's Hospital||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Observed Relapse Free Interval (RFI)
time frame: At relapse, estimated at 6-12 months average.
Median, 1, 2 and 5 year Overall Survival (OS)
time frame: 1, 2 and 5 Years
Median, 1, 2 and 5 year Event Free Survival (EFS)
time frame: 1, 2 and 5 years
Male or female participants at least 13 years old.
- 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).
- 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.
- Age ≥13 years.
- Patients must have recovered sufficiently from all acute adverse effects of prior therapies, excluding alopecia.
- Patients must have an ECOG performance status of 0-2. (Lansky score of 50-100 if < 16 years old).
- 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).
- Patients must have adequate renal function as defined by a serum creatinine of ≤ 1.5 mg/dl.
- 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.
- 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.
- Signed informed consent including, where applicable, the consent of the patient's legal guardian.
- Current extrapulmonary disease.
- Current macroscopic pulmonary lesions.
- Greater than 2 pulmonary recurrences.
- Greater than 4 weeks since thoracotomy rendering patient free of macroscopic disease.
- Females who are pregnant or breast-feeding.
- 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.
- Contraindication to or unwillingness to undergo multiple CT scans and chest X-rays.
- Unwillingness or inability to comply with the study protocol for any other reason.
- 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
|Official title||Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma|
|Principal investigator||Richard Gorlick, MD|
|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.|
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