Clinical Trial: Cancer

AEWS1221 New Diagnosed Metastatic Ewing Sarcoma Study (PRO00003772)

Full Name

AEWS1221: Randomized Phase II Trial Evaluating the Addition of the IGF-IR Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008, IND# 120449) to Multi-agent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma

Description

Currently, there is no standard treatment for metastatic Ewing sarcoma.  Ewing sarcoma is a type of cancer that usually occurs in the bones or the soft tissues around the bones.  If you agree to participate in this research study, you will be randomly assigned to one of two treatment groups (called "regimens").  If you are assigned to Regimen A, you will receive VDC (combination of vincristine, doxorubicin and cyclophosphamide) and IE (combination of Ifosfamide and Etoposide).  Treatment on Regimen A will be about 9 months and is divided into 4 stages.  If you are assigned to Regimen B, you will receive VDC and IE, plus the investigational drug ganitumab.  Treatment on Regimen B will be about 15 months, and is divided into 5 stages.  The stages involved in this study are Induction, Local Control, Consolidation, Metastatic site radiation and Maintenance therapy.  If you are assigned to Regimen A, you will not receive Maintenance therapy.  While you are on the study, you will have evaluations at 3 different times (at the end of Induction, at the end of Cycle 4 of Consolidation, and at the end of Consolidation therapy).  An evaluation means that you will have tests and imaging studies (scans) done to see if the tumor has changed.  

Eligibility

Inclusion Criteria

Must have histologic diagnosis of newly diagnosed Ewing Sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other metastatic site 

Must be 50 years old or younger

Must have normal blood sugar level for age to participate

Must only have had a biopsy of the primary tumor without an attempt to complete or partial resection

Must not have regional node involvement as the only site of disease beyond the primary tumor

Must not have received prior chemotherapy or radiation therapy are not eligible