Status:
TERMINATED
Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Osteosarcoma
Eligibility:
All Genders
2-40 years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01194284
Start Date
December 1 2011
End Date
December 1 2013
Last Update
January 19 2017
Active Locations (1)
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1
AKH Wien Universitätsklinik für Innere Medizin I Klinische Abteilung für Onkologie
Vienna, Austria