Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

January 17, 2017 updated by: Millennium Pharmaceuticals, Inc.

Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

This study is an observational safety surveillance study designed to prospectively assess patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

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

  • Austria
      • Wien, Austria
        • AKH Wien Universitätsklinik für Innere Medizin I Klinische Abteilung für Onkologie

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

2 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice.

Description

Inclusion Criteria

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • Male or female aged 2 to 40 years
  • Confirmed pathological diagnosis of newly-diagnosed, nonmetastatic, resectable, primary, high-grade osteosarcoma
  • Have completed definitive surgery (or other local ablation technique)
  • Have a treatment regimen that includes mifamurtide and a minimum of 2 recognized chemotherapy agents in the treatment of osteosarcoma (cisplatin, doxorubicin, high-dose methotrexate or ifosfamide)
  • Organ function deemed satisfactory to receive planned chemotherapy containing at minimum 2 of the recognized chemotherapy agents in the treatment of osteosarcoma
  • Voluntary Written Consent

Exclusion Criteria

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period
  • History of pericarditis or pleuritis
  • Have low-grade osteosarcoma or parosteal or periosteal sarcoma
  • Have osteosarcoma associated with Paget's disease
  • Current treatment with any anticancer investigational products at the time of enrollment in this study

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High-grade osteosarcoma patients
Drug: Mifamurtide
Mifamurtide will be prescribed to patients with high-grade osteosarcoma as part of their treatment regimen within the context of prevailing standard oncology practice. The recommended dose of mifamurtide is 2 mg/m2. Mifamurtide will be administered for 36 weeks as adjuvant therapy following surgical resection.
Other Names:
  • MEPACT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy)
Time Frame: 36 weeks
  • Adverse events of special interest (AESIs), including important identified and potential risks
  • The frequency and pattern of mifamurtide-related infusion adverse events
36 weeks
The long-term safety profile of mifamurtide during and following treatment (mifamurtide in combination with chemotherapy)
Time Frame: Up to 5 years from the last dose of mifamurtide or until death
Assessment of AESIs, consisting of important identified and potential risks
Up to 5 years from the last dose of mifamurtide or until death

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: Up to 5 years from the last dose of mifamurtide or until death
Up to 5 years from the last dose of mifamurtide or until death
Overall Survival
Time Frame: Up to 5 years from the last dose of mifamurtide or until death
Up to 5 years from the last dose of mifamurtide or until death

Collaborators and Investigators

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

Sponsor

Millennium Pharmaceuticals, Inc.

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

December 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (Estimate)

September 2, 2010

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C23003
  • 2009-017204-89 (EudraCT Number)

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.

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