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

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102531
• Other study ID #: TR02-2421
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 29, 2005
• Last updated: July 7, 2010
• Start date: January 2005
• Est. completion date: March 2008

Study information

• Verified date: July 2010
• Source: Insmed Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• SLIT Cisplatin

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	The Albert Einstein College of Medicine Montefiore Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Insmed Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Response
Primary	Pharmacokinetics
Secondary	Duration of response