Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

NCT ID: NCT01650090

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2018-11-30

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.

Conditions

Pulmonary Relapse of Osteosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ILC

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

Group Type: EXPERIMENTAL

Inhaled Lipid Cisplatin (ILC)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Cisplatin; Lipid cisplatin complex

Eligibility 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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eleison Pharmaceuticals LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Gorlick, MD

Role: PRINCIPAL_INVESTIGATOR

The Children's Hospital at Montefiore

Forrest H Anthony, MD, PhD

Role: STUDY_DIRECTOR

Eleison Pharmaceuticals

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

University of Chicago

Chicago, Illinois, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

The Children's Hospital at Montefiore

The Bronx, New York, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, United States

Primary Children's Medical Center

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

Other Identifiers

EP-ILC-201

Identifier Type: -

Identifier Source: org_study_id