Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Osteosarcoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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High-grade osteosarcoma patients

Mifamurtide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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MEPACT

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

2 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No