Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

NCT01194284 | Terminated DMC

• 2 other identifiers: C230032009-017204-89
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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 prevailing standard oncology practice

Conditions

Osteosarcoma

Outcome Measures

Primary Outcomes (2)

• Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy)

  * Adverse events of special interest (AESIs), including important identified and potential risks * The frequency and pattern of mifamurtide-related infusion adverse events

  36 weeks

• The long-term safety profile of mifamurtide during and following treatment (mifamurtide in combination with chemotherapy)

  Assessment of AESIs, consisting of important identified and potential risks

  Up to 5 years from the last dose of mifamurtide or until death

Secondary Outcomes (2)

• Disease-free survival

  Up to 5 years from the last dose of mifamurtide or until death

• Overall Survival

  Up to 5 years from the last dose of mifamurtide or until death

Study Arms (1)

High-grade osteosarcoma patients

Drug: Mifamurtide

Interventions

Mifamurtide 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.

Also known as: MEPACT

High-grade osteosarcoma patients

Eligibility Criteria

• Age: 2 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (1)

AKH Wien Universitätsklinik für Innere Medizin I Klinische Abteilung für Onkologie

Vienna, Austria

Location

MeSH Terms

Conditions

Osteosarcoma

Interventions

mifamurtide

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 2, 2010
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 19, 2017

Record last verified: 2017-01

Locations

AU (1)