Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

NCT01650090 | Completed Phase 2

• 1 other identifier: EP-ILC-201
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 15

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.

Conditions

Pulmonary Relapse of Osteosarcoma

Keywords

Pulmonary relapse; Osteosarcoma; Lung metastases; Pediatric osteosarcoma; Inhaled chemotherapy; Inhaled Lipid Cisplatin

Outcome Measures

Primary Outcomes (1)

• 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.

  At relapse, estimated at 6-12 months average.

Secondary Outcomes (2)

• Median, 1, 2 and 5 year Overall Survival (OS)

  1, 2 and 5 Years

• Median, 1, 2 and 5 year Event Free Survival (EFS)

  1, 2 and 5 years

Study Arms (1)

ILC

EXPERIMENTAL

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

Drug: Inhaled Lipid Cisplatin (ILC)

Interventions

Inhaled Lipid Cisplatin (ILC) DRUG

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.

Also known as: Cisplatin, Lipid cisplatin complex

ILC

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eleison Pharmaceuticals LLC.: lead

Study Sites (15)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

The Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Osteosarcoma

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Richard Gorlick, MD

  The Children's Hospital at Montefiore

  PRINCIPAL INVESTIGATOR

• Forrest H Anthony, MD, PhD

  Eleison Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 26, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

US (15)