Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

Millennium Pharmaceuticals

Status: Terminated

Conditions: Osteosarcoma

Treatments: Drug: Mifamurtide

Study type: Observational

Funder types: Industry

Identifiers

NCT01194284

2009-017204-89 (EudraCT Number)

C23003

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 2 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

25 participants in 1 patient group

High-grade osteosarcoma patients

Treatment:

Drug: Mifamurtide