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Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
This study is ongoing, but not recruiting participants.
Sponsor:
Eleison Pharmaceuticals LLC.
Information provided by (Responsible Party):
Eleison Pharmaceuticals LLC.
ClinicalTrials.gov Identifier:
NCT01650090
First received: July 20, 2012
Last updated: January 19, 2016
Last verified: January 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Pulmonary Relapse of Osteosarcoma | Drug: Inhaled Lipid Cisplatin (ILC) | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Official Title: | Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma |
Resource links provided by NLM:
Further study details as provided by Eleison Pharmaceuticals LLC.:
Primary Outcome Measures:
- Observed Relapse Free Interval (RFI) [ Time Frame: At relapse, estimated at 6-12 months average. ]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.
Secondary Outcome Measures:
- Median, 1, 2 and 5 year Overall Survival (OS) [ Time Frame: 1, 2 and 5 Years ]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 ]The percentage of patients surviving without disease relapse at 1, 2 and 5 years and the median event free survival.
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ILC
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.
Other Names:
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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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650090
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650090
Locations
| United States, California | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Stanford University Medical Center | |
| Palo Alto, California, United States, 94304 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center | |
| Tampa, Florida, United States, 33612 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| The Children's Hospital at Montefiore | |
| The Bronx, New York, United States, 10467 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Baylor College of Medicine/Texas Children's Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Primary Children's Medical Center | |
| Salt Lake City, Utah, United States, 84113 | |
| United States, Washington | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98105 | |
Sponsors and Collaborators
Eleison Pharmaceuticals LLC.
Investigators
| Principal Investigator: | Richard Gorlick, MD | The Children's Hospital at Montefiore |
| Study Director: | Forrest H Anthony, MD, PhD | Eleison Pharmaceuticals |
More Information
| Responsible Party: | Eleison Pharmaceuticals LLC. |
| ClinicalTrials.gov Identifier: | NCT01650090 History of Changes |
| Other Study ID Numbers: |
EP-ILC-201 |
| Study First Received: | July 20, 2012 |
| Last Updated: | January 19, 2016 |
Keywords provided by Eleison Pharmaceuticals LLC.:
|
Pulmonary relapse Osteosarcoma Lung metastases |
Pediatric osteosarcoma Inhaled chemotherapy Inhaled Lipid Cisplatin |
Additional relevant MeSH terms:
|
Recurrence Osteosarcoma Disease Attributes Pathologic Processes Neoplasms, Bone Tissue Neoplasms, Connective Tissue |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Cisplatin Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 19, 2017