Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

Phase 2

Completed

• Conditions: Pulmonary Relapse of Osteosarcoma
• Interventions: Drug: Inhaled Lipid Cisplatin (ILC)

• Registration Number: NCT01650090
• Lead Sponsor: Eleison Pharmaceuticals LLC.

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 Timeline

• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-26
• Study Start: 2012-08
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Observed Relapse Free Interval (RFI)	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.

Secondary Outcome Measures

Name	Time	Method
Median, 1, 2 and 5 year Overall Survival (OS)	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)	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.

Trial Locations

Locations (15)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Baylor College of Medicine/Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

The Children's Hospital at Montefiore; 🇺🇸 Bronx, New York, United States

Primary Children's Medical Center; 🇺🇸 Salt Lake City, Utah, United States