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Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung

Primary Purpose

Osteosarcoma Metastatic

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cisplatin liposomal
Sponsored by
Insmed Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma Metastatic focused on measuring Osteosarcoma, relapsed, progressive, metastatic, lung

Eligibility Criteria

13 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to the lung Patients with histologically proven, fully malignant high-grade osteosarcoma of bone 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 times upper normal limit ANC of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3 Exclusion Criteria: Grade 3 or higher painful neuropathy persisting after a prior platinum containing regimen Patients who are pregnant or are of childbearing potential and not using methods to avoid pregnancy Concurrent systemic chemotherapy Greater than Grade 2 pulmonary toxicity Pulmonary atelectasis Reactive airway disease which has resulted in hospitalization within the last year or which requires daily treatment with bronchodilator therapy Concurrent serious infections Unstable or serious concurrent medical condition Recent major surgery or thoracic radiation therapy or chemotherapy Significant pulmonary fibrosis secondary to prior radiation Major ventilatory distribution abnormalities Osteosarcoma secondary to radiation or premalignant conditions History of prior malignancy Low grade osteosarcoma, parosteal or periosteal sarcoma

Sites / Locations

  • Memorial Sloan Kettering Cancer Center
  • The Albert Einstein College of Medicine Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cisplatin liposomal 24 mg/m2

Cisplatin liposomal 36 mg/m2

Arm Description

Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.

The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2

Outcomes

Primary Outcome Measures

The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2005
Last Updated
July 5, 2017
Sponsor
Insmed Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00102531
Brief Title
Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung
Official Title
Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 12, 2005 (Actual)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 17, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insmed Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma Metastatic
Keywords
Osteosarcoma, relapsed, progressive, metastatic, lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin liposomal 24 mg/m2
Arm Type
Experimental
Arm Description
Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.
Arm Title
Cisplatin liposomal 36 mg/m2
Arm Type
Experimental
Arm Description
The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2
Intervention Type
Drug
Intervention Name(s)
Cisplatin liposomal
Other Intervention Name(s)
SLIT Cisplatin
Primary Outcome Measure Information:
Title
The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.
Time Frame
4 to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to the lung Patients with histologically proven, fully malignant high-grade osteosarcoma of bone 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 times upper normal limit ANC of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3 Exclusion Criteria: Grade 3 or higher painful neuropathy persisting after a prior platinum containing regimen Patients who are pregnant or are of childbearing potential and not using methods to avoid pregnancy Concurrent systemic chemotherapy Greater than Grade 2 pulmonary toxicity Pulmonary atelectasis Reactive airway disease which has resulted in hospitalization within the last year or which requires daily treatment with bronchodilator therapy Concurrent serious infections Unstable or serious concurrent medical condition Recent major surgery or thoracic radiation therapy or chemotherapy Significant pulmonary fibrosis secondary to prior radiation Major ventilatory distribution abnormalities Osteosarcoma secondary to radiation or premalignant conditions History of prior malignancy Low grade osteosarcoma, parosteal or periosteal sarcoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renu Gupta, MD
Organizational Affiliation
Transave Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richard Gorlick, MD
Organizational Affiliation
The Albert Einstein College of Medicine Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
The Albert Einstein College of Medicine Montefiore Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23255417
Citation
Chou AJ, Gupta R, Bell MD, Riewe KO, Meyers PA, Gorlick R. Inhaled lipid cisplatin (ILC) in the treatment of patients with relapsed/progressive osteosarcoma metastatic to the lung. Pediatr Blood Cancer. 2013 Apr;60(4):580-6. doi: 10.1002/pbc.24438. Epub 2012 Dec 19.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23255417
Description
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Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung

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