Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

August 5, 2019 updated by: Eleison Pharmaceuticals LLC.
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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Bronx, New York, United States, 10467
        • The Children's Hospital at Montefiore
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine/Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Medical Center
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: ILC
Inhaled Lipid Cisplatin (ILC) will be administered every two weeks via nebulization and inhalation.
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

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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1, 2 and 5 Years
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.
1, 2 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard Gorlick, MD, The Children's Hospital at Montefiore
  • Study Director: Forrest H Anthony, MD, PhD, Eleison Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimate)

July 26, 2012

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

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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