- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01650090
Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Palo Alto, California, United States, 94304
- Stanford University Medical Center
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Clinic Foundation
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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New York
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Bronx, New York, United States, 10467
- The Children's Hospital at Montefiore
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt-Ingram Cancer Center
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
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Houston, Texas, United States, 77030
- Baylor College of Medicine/Texas Children's Hospital
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Utah
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Salt Lake City, Utah, United States, 84113
- Primary Children's Medical Center
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ILC
Inhaled Lipid Cisplatin (ILC) will be administered every two weeks via nebulization and inhalation.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observed Relapse Free Interval (RFI)
Time Frame: At relapse, estimated at 6-12 months average.
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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.
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At relapse, estimated at 6-12 months average.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median, 1, 2 and 5 year Overall Survival (OS)
Time Frame: 1, 2 and 5 Years
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The percentage of patients alive at 1, 2 and 5 years and the median overall survival.
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1, 2 and 5 Years
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Median, 1, 2 and 5 year Event Free Survival (EFS)
Time Frame: 1, 2 and 5 years
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The percentage of patients surviving without disease relapse at 1, 2 and 5 years and the median event free survival.
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1, 2 and 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard Gorlick, MD, The Children's Hospital at Montefiore
- Study Director: Forrest H Anthony, MD, PhD, Eleison Pharmaceuticals
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EP-ILC-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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