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

Insmed

Status and phase: Completed; Phase 2; Phase 1

Conditions: Osteosarcoma Metastatic

Treatments: Drug: Cisplatin liposomal

Study type: Interventional

Funder types: Industry

Identifiers

NCT00102531

TR02-2421

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 13 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Cisplatin liposomal 24 mg/m2

Experimental group

Description:

Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.

Treatment:

Drug: Cisplatin liposomal

Cisplatin liposomal 36 mg/m2

Experimental group

Description:

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

Treatment:

Drug: Cisplatin liposomal