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

• Status: Completed
• Trial end date: 2008-03-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Insmed Incorporated
• Treatments: Cisplatin

Criteria

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