Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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 prevailing standard oncology practice

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Mifamurtide

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