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

Phase 1

Completed

• Conditions: Osteosarcoma Metastatic
• Interventions: Drug: Cisplatin liposomal

• Registration Number: NCT00102531
• Lead Sponsor: Insmed Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-12
• Study First Submitted QC: 2005-01-28
• Study First Submitted: 2005-01-29
• Study First Posted: 2005-01-31
• Primary Completion: 2008-03
• Study Completion: 2008-03-17
• Status Verified: 2017-07
• Results First Submitted: 2017-07-05
• Results First Submitted QC: 2017-07-05
• Last Update Submitted: 2017-07-05
• Results First Posted: 2017-08-01
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cisplatin liposomal 24 mg/m2	Cisplatin liposomal	Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.
Cisplatin liposomal 36 mg/m2	Cisplatin liposomal	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

The Albert Einstein College of Medicine Montefiore Medical Center; 🇺🇸 New York, New York, United States