logo Hematology/Oncology Research Studies: Open for Enrollment Date: 10/22/18

Category: ONCOLOGY: EARLY PHASE

Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma

NCT#/Phase: NCT02306161
Phase 3
IRB#: 2015-003
Description: This study tests to determine if event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy is improved with the addition of ganitumab (AMG 479). Subjects are randomized at study entry to the comparator arm with interval compressed multiagent chemotherapy or to the experimental arm with the interval compressed multiagent chemotherapy and ganitumab. Regimen A (VDC/IE) and Regimen B (VDC/IE + ganitumab) will both receive 5 phases of therapy. (AMG 479, NSC# 750008, IND# 120449)
Inclusion: Indidivuals who are <= 50 years of age with histologic disease 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.
Enrollment Status: Open for enrollment
Sponsor: Children's Oncology Group
Principal Investigator(s): Carla Golden, MD
Contact(s): Christine Ho (510-428-3885 x 2609)
Diane Olzewski (510-428-3885 x 3246)
Study Link: https://clinicaltrials.gov/ct2/show/NCT02306161

UCSF Benioff Children's Hospital Oakland • 747 52nd Street, Oakland, California 94609 &bull Phone: (510) 428-3000