Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

Osteosarcoma Clinical Trial

Official title:

Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01194284
• Other study ID #: C23003
• Secondary ID: 2009-017204-89
• Status: Terminated
• Phase: N/A
• First received: September 1, 2010
• Last updated: January 17, 2017
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2017
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Austria	AKH Wien Universitätsklinik für Innere Medizin I Klinische Abteilung für Onkologie	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Disease-free survival		Up to 5 years from the last dose of mifamurtide or until death
Secondary	Overall Survival		Up to 5 years from the last dose of mifamurtide or until death