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Osteosarcoma1999-A Study Of Intensive Chemotherapy for Osteosarcoma

St. Jude Children's Research Hospital
Arkansas Children's Hospital
Washington University School of Medicine
Hospital Calvo Mackenna

Purpose

St. Jude Children's Research Hospital researchers want to determine which drugs are most effective in treating osteosarcoma. They also want to limit side effects as much as possible. This trial is evaluating ifosfamide, carboplatin, and doxorubicin in an up-front window before surgery for localized and resectable osteosarcoma. High-dose methotrexate, which may interfere with the dose-intensive delivery of other agents, has been eliminated from OS99.

Primary Outcomes:

To compare the tumor response to chemotherapy with three drugs (ifosfamide, carboplatin, and doxorubicin) used before surgery in an earlier St.Jude Children's Research Hospital study.

Secondary Outcomes:

• To study the accuracy of dynamic contrast-enhanced MR imaging in assessing the degree of response
• To study the feasibility of administering therapy on an outpatient basis
• To study whether a 3-cm surgical margin of normal bone (rather than the 5-cm standard margin)provides satisfactory; resection of the primary tumor
• To study biological markers including telomerase activity and DNA index
• To learn what subjects and parents think about the of life during and after treatment
• Expected Total Enrollment:  80

Eligibility

Ages: up to 25 Years

Inclusion Criteria:

• All subjects with histologically proven high-grade osteosarcoma,chondrosarcoma, MFH, fibrosarcoma or chondrosarcoma of bone, whose tumors are potentially resectable (either by limb sparing, en bloc resection, or amputation) and have no evidence of metastasis.
• Adequate liver, renal and cardiac function.
• Age: Younger than 25 years old

Exclusion Criteria:

• Prior chemotherapy

Location and Contact Information

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States; Recruiting
Najat C Daw, MD: 866-278-5833; E-mail