Ewing Sarcoma Treatment with Combination Chemotherapy Including Ganitumab – Phase II

Adding the IGF-1R Monoclonal Antibody Ganitumab to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma

Protocol Description

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.

Study Level: Phase II

Eligibility Criteria

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

Requirements

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

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AEWS1221)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
412-692-5055