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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCisplatin liposomal

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 1, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Insmed Incorporated

Study sponsor

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

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How this study is categorized

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

Disease setting

Metastatic or stage IV→Recurrent or relapsed→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

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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