Inhalation SLIT Cisplatin for the Treatment of Osteosarcoma Metastatic to the Lung
Phase Ib/IIa study to determine the safety and efficacy of inhaled SLIT Cisplatin administered every other week to patients with Osteosarcoma who have disease that has spread to the lung.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung|
- Duration of response
|Study Start Date:||January 2005|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Osteosarcoma, preferentially metastasizes to the lung. The presence of lung metastases has a major impact on the prognosis of patients with osteosarcoma. Upon surgical removal of the tumor in the lung, new pulmonary metastases often recur within months suggesting micro-metastatic disease resistant to systemic chemotherapy.
The Sustained release lipid inhalation targeting (SLIT) technology offers the potential ability to attain a prolonged therapeutic effect of cisplatin in the lung by sustained release. The ability to give SLIT Cisplatin by inhalation directly to the lung permits high drug levels at the site of disease with low systemic exposure.
Patients will receive SLIT Cisplatin by inhalation for a 14-day treatment cycle in this phase Ib/IIa, two-center, open-label, study designed to characterize the maximum tolerated dose. Clinical efficacy endpoints will be included and compared to historical controls, in addition to pharmacokinetics characterization. Efficacy will be evaluated after at least 2 cycles of therapy. Safety data, including laboratory parameters and adverse events will be collected to determine the qualitative and quantitative toxicity, and reversibility of toxicity, of SLIT Cisplatin. Pulmonary function tests will be performed at baseline, prior to each course and at off-study.
|United States, New York|
|The Albert Einstein College of Medicine Montefiore Medical Center|
|New York, New York, United States, 10467|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Renu Gupta, MD||Transave Inc.|
|Principal Investigator:||Richard Gorlick, MD||The Albert Einstein College of Medicine Montefiore Medical Center|