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
  Purpose

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.


Condition Intervention Phase
Osteosarcoma
Drug: SLIT Cisplatin
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Insmed:

Primary Outcome Measures:
  • Safety
  • Response
  • Pharmacokinetics

Secondary Outcome Measures:
  • Duration of response

Estimated Enrollment: 21
Study Start Date: January 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102531

Locations
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
Sponsors and Collaborators
Insmed
Investigators
Study Chair: Renu Gupta, MD Transave Inc.
Principal Investigator: Richard Gorlick, MD The Albert Einstein College of Medicine Montefiore Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00102531     History of Changes
Other Study ID Numbers: TR02-2421
Study First Received: January 29, 2005
Last Updated: July 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Insmed:
Osteosarcoma
relapsed
progressive
metastatic
lung

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 01, 2014