Status:
COMPLETED
Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung
Lead Sponsor:
Insmed Incorporated
Conditions:
Osteosarcoma Metastatic
Eligibility:
All Genders
13-50 years
Phase:
PHASE1
PHASE2
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/...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00102531
Start Date
January 12 2005
End Date
March 17 2008
Last Update
August 1 2017
Active Locations (2)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
2
The Albert Einstein College of Medicine Montefiore Medical Center
New York, New York, United States, 10467