Inhalation SLIT Cisplatin for the Treatment of Osteosarcoma Metastatic to the Lung - Full Text View

Sponsored by:	Transave
Information provided by:	Transave
ClinicalTrials.gov Identifier:	NCT00102531

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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:

Drug Information available for: Cisplatin

U.S. FDA Resources

Further study details as provided by Transave:

Primary Outcome Measures:

Safety
Response
Pharmacokinetics

Secondary Outcome Measures:

Duration of response

Estimated Enrollment:	21
Study Start Date:	January 2005
Estimated Study Completion Date:	January 2007

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

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

Contacts

Contact: Connie . Mackinson, BS,MT

732-438-9434 ext 12

cmackinson@transaveinc.coom

Locations

United States, New York
The Albert Einstein College of Medicine Montefiore Medical Center	Recruiting
New York, New York, United States, 10467
Contact: Richard Gorlick, MD 718-741-2333 rgorlick@montefiore.org
Contact: Moshe Bell, MD 718.741.2342 mobell@montefiore.org
Principal Investigator: Richard Gorlick, MD
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: Paul Meyers, MD 212-639-5952 meyersp@mskcc.org
Contact: Alex Chou, MD 212-639-6057 choua@mskcc.org
Principal Investigator: Paul Meyers, MD

Sponsors and Collaborators

Transave

Investigators

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

More Information

No publications provided

Study ID Numbers:	TR02-2421
Study First Received:	January 29, 2005
Last Updated:	August 7, 2006
ClinicalTrials.gov Identifier:	NCT00102531 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Transave:

Osteosarcoma
relapsed
progressive
metastatic
lung

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Radiation-Sensitizing Agents

Cisplatin
Sarcoma
Osteogenic Sarcoma
Osteosarcoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Osteosarcoma
Pharmacologic Actions
Neoplasms, Connective and Soft Tissue
Neoplasms

Neoplasms, Bone Tissue
Cisplatin
Radiation-Sensitizing Agents
Therapeutic Uses
Sarcoma
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on September 11, 2009