IRB Number:

06-002062

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

Study doctors would like to find out how best to treat subjects with osteosarcoma by comparing how subjects do when treated with different anti-cancer drugs. The standard anti-cancer drugs used to treat subjects with osteosarcoma are methotrexate, doxorubicin (also called adriamycin) and cisplatin. These three drugs together are called MAP. This study is being done to:
- See if adding ifosfamide and etoposide (VP-16) to chemotherapy will help get rid of the disease in subjects who have a poor tumor response to MAP alone.
- See if adding a "biologic" drug called interferon after MAP chemotherapy can help get rid of the disease in subjects who have a good tumor response to standard chemotherapy. This study will use pegylated interferon alfa-2b, interferon that has been changed to last longer in the body so it can be given less often.

Who is Eligible to Participate in the Study?

- Ages 5 years to 40 on date of diagnostic biopsy.
- Diagnosed with high-grade osteosarcoma, including second malignancies, for which surgical removal is recommended.
- No previous treatment for osteosarcoma or previous chemotherapy for any disease allowed.
*More specific, detailed eligibility and/or exclusion criteria are associated with this trial.

What is Involved With this Study?

- History and physical exam
- Blood tests
- Urine tests
- Pregnancy test (given to females of childbearing age before treatment)
- Echocardiogram (picture of the heart in motion)
- MRI (magnetic resonance imaging) of disease sites
- X-ray of disease sites and the chest
- CT scan (an X-ray procedure) of disease sites and the chest
- Bone scan (picture of the bones)
- Audiogram (hearing test)
- Nuclear medicine scans
- Treatment with medications, given by vein.
After 10 weeks of chemotherapy, patients will have surgery to take out the tumor(s). The treatment patients will get during the second part of the study will depend on if they have a good or a poor tumor response.

How long will the Study run?

Patients will be in the study for about 7 to 10 months, depending on which treatment group they are assigned to following surgery. Patients will have physical exams and blood tests for a few years after treatment so that study doctors can watch for any effects of treatment.

Sponsor(s): Children's Oncology Group (COG)

Study Activation/Registration Date: 06/21/2006

IRB Review and Approval Date: 05/04/2006

Study Type: Treatment

Projected Accrual: 1400

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Carola Arndt, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/23/2008