Neoplasms

Symptoms and General Pathology

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Neoplasm Metastasis

Respiratory Aspiration

Recurrence

Osteosarcoma

Disease Attributes

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Cisplatin

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

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.

Inhaled Lipid Cisplatin (ILC)

Richard Gorlick, MD

Forrest H Anthony, MD, PhD

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.

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.

Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma

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.

The percentage of patients alive at 1, 2 and 5 years and the median overall survival.

The percentage of patients surviving without disease relapse at 1, 2 and 5 years and the median event free survival.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma	NCT01650090	Pulmonary Relap...	Inhaled Lipid C...	13 Years -	Eleison Pharmaceuticals LLC.
Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma	NCT01650090	Pulmonary Relap...	Inhaled Lipid C...	13 Years -	Eleison Pharmaceuticals LLC.

Spots Global Cancer Trial Database for pulmonary relapse of osteosarcoma