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Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

Primary Purpose

Pulmonary Relapse of Osteosarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Inhaled Lipid Cisplatin (ILC)
Sponsored by
Eleison Pharmaceuticals LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Relapse of Osteosarcoma focused on measuring Pulmonary relapse, Osteosarcoma, Lung metastases, Pediatric osteosarcoma, Inhaled chemotherapy, Inhaled Lipid Cisplatin

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Los Angeles
  • Stanford University Medical Center
  • H. Lee Moffitt Cancer Center
  • University of Chicago
  • Ochsner Clinic Foundation
  • Dana-Farber Cancer Institute
  • Mayo Clinic
  • Washington University School of Medicine
  • The Children's Hospital at Montefiore
  • Memorial Sloan-Kettering Cancer Center
  • Vanderbilt-Ingram Cancer Center
  • UT Southwestern Medical Center
  • Baylor College of Medicine/Texas Children's Hospital
  • Primary Children's Medical Center
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ILC

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 20, 2012
Last Updated
August 5, 2019
Sponsor
Eleison Pharmaceuticals LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT01650090
Brief Title
Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
Official Title
Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eleison Pharmaceuticals LLC.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Relapse of Osteosarcoma
Keywords
Pulmonary relapse, Osteosarcoma, Lung metastases, Pediatric osteosarcoma, Inhaled chemotherapy, Inhaled Lipid Cisplatin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ILC
Arm Type
Experimental
Arm Description
Inhaled Lipid Cisplatin (ILC) will be administered every two weeks via nebulization and inhalation.
Intervention Type
Drug
Intervention Name(s)
Inhaled Lipid Cisplatin (ILC)
Other Intervention Name(s)
Cisplatin, Lipid cisplatin complex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Observed Relapse Free Interval (RFI)
Description
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.
Time Frame
At relapse, estimated at 6-12 months average.
Secondary Outcome Measure Information:
Title
Median, 1, 2 and 5 year Overall Survival (OS)
Description
The percentage of patients alive at 1, 2 and 5 years and the median overall survival.
Time Frame
1, 2 and 5 Years
Title
Median, 1, 2 and 5 year Event Free Survival (EFS)
Description
The percentage of patients surviving without disease relapse at 1, 2 and 5 years and the median event free survival.
Time Frame
1, 2 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Gorlick, MD
Organizational Affiliation
The Children's Hospital at Montefiore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Forrest H Anthony, MD, PhD
Organizational Affiliation
Eleison Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine/Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

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