Pulmonary Relapse of Osteosarcoma Clinical Trial
Official title:
Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
| Verified date | August 2019 |
| Source | Eleison Pharmaceuticals LLC. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | November 2018 |
| Est. primary completion date | November 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 13 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | The Children's Hospital at Montefiore | Bronx | New York |
| United States | University of Chicago | Chicago | Illinois |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | Baylor College of Medicine/Texas Children's Hospital | Houston | Texas |
| United States | Children's Hospital Los Angeles | Los Angeles | California |
| United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
| United States | Stanford University Medical Center | Palo Alto | California |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Primary Children's Medical Center | Salt Lake City | Utah |
| United States | Seattle Children's Hospital | Seattle | Washington |
| United States | H. Lee Moffitt Cancer Center | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Eleison Pharmaceuticals LLC. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | At relapse, estimated at 6-12 months average. | |
| Secondary | 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. | 1, 2 and 5 Years | |
| Secondary | 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. | 1, 2 and 5 years |