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Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma


N/A
2 Years
40 Years
Open (Enrolling)
Both
Osteosarcoma

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Trial Information

Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

36 weeks

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

European Union: European Medicines Agency

Study ID:

C23003

NCT ID:

NCT01194284

Start Date:

December 2011

Completion Date:

October 2019

Related Keywords:

  • Osteosarcoma
  • Osteosarcoma

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