Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01194284
First received: September 1, 2010
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Osteosarcoma
Drug: Mifamurtide

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy) [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
    • Adverse events of special interest (AESIs), including important identified and potential risks
    • The frequency and pattern of mifamurtide-related infusion adverse events

  • 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 ] [ Designated as safety issue: Yes ]
    Assessment of AESIs, consisting of important identified and potential risks


Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: Up to 5 years from the last dose of mifamurtide or until death ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Up to 5 years from the last dose of mifamurtide or until death ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: December 2011
Estimated Study Completion Date: November 2021
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: MEPACT

  Eligibility

Ages Eligible for Study:   2 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194284

Locations
Austria
AKH Wien Universitätsklinik für Innere Medizin I Klinische Abteilung für Onkologie
Wien, Austria
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01194284     History of Changes
Other Study ID Numbers: C23003, 2009-017204-89
Study First Received: September 1, 2010
Last Updated: January 31, 2014
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Sarcoma
Mifamurtide
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014