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

July 5, 2017 updated by: Insmed Incorporated

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10467
        • The Albert Einstein College of Medicine Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cisplatin liposomal 24 mg/m2
Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.
Drug: Cisplatin liposomal
Other Names:
  • SLIT Cisplatin
Experimental: Cisplatin liposomal 36 mg/m2
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
Drug: Cisplatin liposomal
Other Names:
  • SLIT Cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insmed Incorporated

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 17, 2008

Study Registration Dates

First Submitted

January 29, 2005

First Submitted That Met QC Criteria

January 28, 2005

First Posted (Estimate)

January 31, 2005

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR02-2421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteosarcoma Metastatic

Clinical Trials on Cisplatin liposomal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe