Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

This study is currently recruiting participants.
Verified January 2014 by Eleison Pharmaceuticals LLC.
Sponsor:
Information provided by (Responsible Party):
Eleison Pharmaceuticals LLC.
ClinicalTrials.gov Identifier:
NCT01650090
First received: July 20, 2012
Last updated: January 21, 2014
Last verified: January 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2015
Estimated Primary Completion Date: December 2014 (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:
  • Cisplatin
  • Lipid cisplatin complex

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650090

Contacts
Contact: Eleison Pharmaceuticals 215-554-3530 info@eleison-pharma.com

Locations
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Henry Yepez    323-361-5881    hmyepez@chla.usc.edu   
Contact: Lakshmi Damerla    323.361.8359    ldamerla@chla.usc.edu   
Principal Investigator: Leo Mascarenhas, MD, MS         
United States, Florida
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Damon Reed, MD    813-745-4292    Damon.Reed@moffitt.org   
Contact: Courtney Yates, RN    (813) 745-4292    Courtney.Yates@moffitt.org   
Principal Investigator: Damon Reed, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Navin Pinto, MD    773-702-6808    npinto1@peds.bsd.uchicago.edu   
Principal Investigator: Navin Pinto, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Aidan Combs    314-747-8368    acombs@DOM.wustl.edu   
Contact: Cheryl Callahan    314-286-2584    ccallaha@dom.wustl.edu   
Principal Investigator: Brian A Van Tine, MD, PhD         
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Alex Chou, MD    212-639-6057    choua@mskcc.org   
Contact: Judy Persaud-Moore, MPH    646-888-5722    persauj1@mskcc.org   
Principal Investigator: Alex Chou, MD         
Sub-Investigator: Paul Meyers, MD         
The Children's Hospital at Montefiore Recruiting
The Bronx, New York, United States, 10467
Contact: Richard Gorlick, MD    718-741-2342    rgorlick@montefiore.org   
Contact: Jonathan Gill, MD    718-741-2342    jgill@montefiore.org   
Principal Investigator: Richard Gorlick, MD         
Sub-Investigator: Jonathan Gill, MD         
United States, Texas
Baylor College of Medicine/Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Matteo Trucco, MD    832-824-4260    trucco@bcm.edu   
Contact: Brittany Pena    832-824-1514    brpena@txch.org   
Principal Investigator: Matteo Trucco, MD         
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Salman Yakub    801-213-3765    Salman.Yakub@hsc.utah.edu   
Contact: Clinic Number    801-662-4700      
Principal Investigator: Jennifer Wright, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Damon Jacobson    206-884-7851    damon.jacobson@seattlechildrens.org   
Contact: Doug Hawkins, MD    206 987-3096    doug.hawkins@seattlechildrens.org   
Principal Investigator: Doug Hawkins, MD         
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

No publications provided

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 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eleison Pharmaceuticals LLC.:
Pulmonary relapse
Osteosarcoma
Lung metastases
Pediatric osteosarcoma
Inhaled chemotherapy
Inhaled Lipid Cisplatin

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2014