CompletedPhase 1 / Phase 2NCT00102531

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

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations2
SponsorInsmed Incorporated
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Insmed Incorporated
Interventions being studied
Drug: Cisplatin liposomal
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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