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

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteosarcoma Metastatic

Intervention / Treatment
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* Drug: Cisplatin liposomal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cisplatin liposomal 24 mg/m2<br>Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles. | Drug: Cisplatin liposomal<br> <br> * Other names: SLIT Cisplatin;|
| Experimental: Cisplatin liposomal 36 mg/m2<br>The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2 | Drug: Cisplatin liposomal<br> <br> * Other names: SLIT Cisplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery. |  | 4 to 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsed, Osteosarcoma, progressive, metastatic, lung