Randomized Phase II Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479 NSC# 750008) to Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma
Sandeep Batra, MD
Primary Investigator
Brief description of study
This randomized phase II trial 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.
Detailed description of study
The purpose of this study is to compare the event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab (AMG 479).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Ewing Sarcoma,metastatic Ewing sarcoma
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Age: - 50 Years
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Gender: All
Inclusion Criteria
Patients with histologic diagnosis (by institutional pathologist) 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
Contralateral pleural effusion and/or contralateral pleural nodules
Distant lymph node involvement
Patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection
Exclusion Criteria
Patients with regional node involvement as their only site of disease beyond the primary tumor
Patients whose primary tumors arise in the intra-dural soft tissue (eg. brain and spinal cord)
Patients who have received prior chemotherapy or radiation therapy
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained; lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of protocol therapy; sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of protocol therapy
Patients with known pre-existing diabetes mellitus
Patients receiving chronic pharmacologic doses of corticosteroids; patients receiving chronic inhaled corticosteroids or chronic physiologic replacement doses of corticosteroids are eligible
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