Overview

This trial is active, not recruiting.

Condition osteosarcoma
Treatment mifamurtide
Sponsor Millennium Pharmaceuticals, Inc.
Start date December 2011
End date December 2013
Trial size 25 participants
Trial identifier NCT01194284, 2009-017204-89, C23003

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
mifamurtide MEPACT
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.

Primary Outcomes

Measure
Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy)
time frame: 36 weeks
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

Secondary Outcomes

Measure
Disease-free survival
time frame: Up to 5 years from the last dose of mifamurtide or until death
Overall Survival
time frame: Up to 5 years from the last dose of mifamurtide or until death

Eligibility Criteria

Male or female participants from 2 years up to 40 years old.

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

Additional Information

Official title Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc..