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This multicenter trial by the Children’s Oncology Group studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Investigators believe that monoclonal antibodies, such as ganitumab, may block tumor growth in different ways by targeting certain cells. Ganitumab has been shown activity against Ewing sarcoma in both laboratory studies and prior clinical trials involving adults.
Subject to certain exclusion criteria, this study is accepting patients of both genders up to age 50, who have been newly diagnosed with Ewing sarcoma that has spread to other parts of the body.
Males and Females: Up to age 50
Study participants will be randomly assigned to either receive standard combination chemotherapy for their condition or chemotherapy that includes ganitumab. For both, the treatment plan involves induction therapy (12 weeks), local control (surgery, irradiation or both), consolidation therapy (16 weeks), and metastatic site irradiation, if required. For patients receiving ganitumab, a 6-month maintenance regimen is added as a final stage.
Visits: Same as required for standard care for this condition
Duration: Approximately 9 to 15 months, depending on the study arm in which the patient is enrolled
Children’s Oncology Group (AEWS1221)
National Cancer Institute
Study Description at National Institutes of Health
Cancer and Blood Disorder Research
Jean Tersak, MD
For more information about the study or enrollment, please contact:
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UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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