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Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01650090
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Eleison Pharmaceuticals LLC.

Tracking Information
First Submitted Date  ICMJE July 20, 2012
First Posted Date  ICMJE July 26, 2012
Last Update Posted Date August 7, 2019
Study Start Date  ICMJE August 2012
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
Official Title  ICMJE Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pulmonary Relapse of Osteosarcoma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: ILC
Inhaled Lipid Cisplatin (ILC) will be administered every two weeks via nebulization and inhalation.
Intervention: Drug: Inhaled Lipid Cisplatin (ILC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2019)
28
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2012)
50
Actual Study Completion Date  ICMJE November 2018
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01650090
Other Study ID Numbers  ICMJE EP-ILC-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eleison Pharmaceuticals LLC.
Study Sponsor  ICMJE Eleison Pharmaceuticals LLC.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Gorlick, MD The Children's Hospital at Montefiore
Study Director: Forrest H Anthony, MD, PhD Eleison Pharmaceuticals
PRS Account Eleison Pharmaceuticals LLC.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP