Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung

Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung

Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.

Inclusion Criteria:

• Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to the lung
• Patients with histologically proven, fully malignant high-grade osteosarcoma of bone
• Measureable pulmonary metastases
• Less than grade 3 neuropathies, insignificant decreases in cardiac or auditory function
• ECOG performance status of 0, 1 or 2
• FEV1 of 50% or greater of predicted value
• FEV1/FVC ratio of 65% or greater
• Serum creatinine of ≤ 1.5 mg/dl
• Total bilirubin ≤ 1.5mg/dl and SGOT or SGPT < 2.5 times upper normal limit
• ANC of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3

Exclusion Criteria:

• Grade 3 or higher painful neuropathy persisting after a prior platinum containing regimen
• Patients who are pregnant or are of childbearing potential and not using methods to avoid pregnancy
• Concurrent systemic chemotherapy
• Greater than Grade 2 pulmonary toxicity
• Pulmonary atelectasis
• Reactive airway disease which has resulted in hospitalization within the last year or which requires daily treatment with bronchodilator therapy
• Concurrent serious infections
• Unstable or serious concurrent medical condition
• Recent major surgery or thoracic radiation therapy or chemotherapy
• Significant pulmonary fibrosis secondary to prior radiation
• Major ventilatory distribution abnormalities
• Osteosarcoma secondary to radiation or premalignant conditions
• History of prior malignancy
• Low grade osteosarcoma, parosteal or periosteal sarcoma