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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

September 1, 2010
January 31, 2014
December 2011
December 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01194284 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Disease status [ Time Frame: Up to 5 years from the last dose of mifamurtide or until death ] [ Designated as safety issue: No ]
    Dates and sites of relapse
  • 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 ]
Not Provided
Not Provided
 
Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
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

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Osteosarcoma
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
High-grade osteosarcoma patients
Intervention: Drug: Mifamurtide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
November 2021
December 2013   (final data collection date for primary outcome measure)

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
Both
2 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01194284
C23003, 2009-017204-89
Yes
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP