Inhalation SLIT Cisplatin (Liposomal) for the Treatment of 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.
Checked against the public recordLast updated Aug 1, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Insmed Incorporated
- Interventions being studied
- Drug: Cisplatin liposomal
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Memorial Sloan Kettering Cancer CenterNew York, New York
- The Albert Einstein College of Medicine Montefiore Medical CenterNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 1, 2017. Always confirm current availability with the study team.