Inhalation SLIT Cisplatin for the Treatment of Osteosarcoma Metastatic to the Lung

This study has been completed.
Sponsor:
Information provided by:
Insmed
ClinicalTrials.gov Identifier:
NCT00102531
First received: January 29, 2005
Last updated: July 7, 2010
Last verified: July 2010

January 29, 2005
July 7, 2010
January 2005
March 2008   (final data collection date for primary outcome measure)
  • Safety
  • Response
  • Pharmacokinetics
Same as current
Complete list of historical versions of study NCT00102531 on ClinicalTrials.gov Archive Site
Duration of response
Same as current
Not Provided
Not Provided
 
Inhalation SLIT Cisplatin for the Treatment of Osteosarcoma Metastatic to the Lung
Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive 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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteosarcoma
Drug: SLIT Cisplatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to the lung
  • 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 x upper normal limit
  • ANC of >/= 1,000/mm3 and platelet count of >= 100,000/mm3

Exclusion Criteria:

  • Grade 3 or higher neuropathy
  • Concurrent systemic chemotherapy
  • Pulmonary atelectasis
  • Significant reactive airway disease
  • Concurrent serious infections
  • Unstable or serious concurrent medical condition
  • Recent major surgery
  • Significant pulmonary fibrosis
  • Major ventilatory distribution abnormalities
  • Osteosarcoma secondary to radiation or premalignant conditions
  • History of prior malignancy
  • Low grade osteosarcoma, parosteal or periosteal sarcoma
Both
13 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102531
TR02-2421
Not Provided
Not Provided
Insmed
Not Provided
Study Chair: Renu Gupta, MD Transave Inc.
Principal Investigator: Richard Gorlick, MD The Albert Einstein College of Medicine Montefiore Medical Center
Insmed
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP