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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 29, 2005

Last Updated Date

July 7, 2010

Start Date ^ICMJE

January 2005

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety
Response
Pharmacokinetics

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00102531 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of response

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Osteosarcoma

Intervention ^ICMJE

Drug: SLIT Cisplatin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

13 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00102531

Other Study ID Numbers ^ICMJE

TR02-2421

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Insmed

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Renu Gupta, MD	Transave Inc.
Principal Investigator:	Richard Gorlick, MD	The Albert Einstein College of Medicine Montefiore Medical Center

Information Provided By

Insmed

Verification Date

July 2010

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

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