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Protocol No.AEWS1221Principal InvestigatorYork, Teresa
PhasePhase II
Age GroupBoth
TitleRandomized Phase II Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma
DescriptionIn this study, researchers want to find out if we can improve the treatment for subjects with metastatic EWS by adding a new experimental drug called ganitumab to the commonly used combination of drugs for EWS (called VDC/IE). Subjects are people who agree to take part in this study. Ganitumab is an experimental drug that has not yet been approved by the Food and Drug Administration (FDA) for the treatment of metastatic EWS. Researchers want to find out how effective the combination of VDC/IE + ganitumab is by comparing it with the combination of VDC/IE.

Ganitumab is a type of antibody designed to inhibit a protein called Insulin-Like Growth Factor-1 Receptor (IGF-1R). Antibodies are used by the body’s immune system to fight foreign or diseased cells. IGF-1R is a molecule that is usually found on EWS cells and can promote cancer growth. Ganitumab is an antibody designed to stop the function of IGF-1R. By blocking IGF-1R, ganitumab may block the growth of EWS cells.

The combination of chemotherapy and other types of IGF-IR antibodies has been used to treat children and adults with different types of cancer. In laboratory studies, ganitumab has been shown to work against some types of childhood cancer, including EWS. In previous studies, ganitumab has been given to adults with cancer, including EWS. Ganitumab has not yet been given to children with cancer. The combination of VDC/IE + ganitumab has not yet been tested in people and is therefore considered experimental.

The overall goal of the study is to find out what effects (good and/or bad) ganitumab given with the VDC/IE combination has on children and young adults with metastatic Ewing sarcoma.

In addition to these goals, we would like to answer some biology and imaging research questions that might benefit future patients. These studies are described in detail later in this form.
TreatmentMulti-Chemo with or without experimental monoclonal antibody Ganitumab
Key Eligibility-Patients <= 50 years of age at enrollment will be eligible for this study.
Applicable Disease SitesMultiple
Soft Tissue
Therapies InvolvedChemotherapy multiple agents systemic
Immunotherapy
Drugs InvolvedAdriamycin (doxorubicin)
Ifosfamide
MESNA
VP-16 (etoposide)
Vincristine
cyclophosphamide
doxorubicin
etoposide
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02306161
ContactGreenebaum Cancer Center Natalie McNally, MS, CCRP Phone:410-328-2808
Pager:410-328-2337 #7041
Email:nmcnally@peds.umaryland.edu
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