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
Investigating Combination Chemotherapy for Ewing Sarcoma Spread to Other Parts of the Body
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: metastatic Ewing sarcoma,Ewing Sarcoma,metastatic,ewing,sarcoma,cancer,oncology
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Age: 50 years or below
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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
This study investigates the effectiveness of combination chemotherapy with or without an investigational medication in treating patients with Ewing sarcoma that has spread to other parts of the body. Ewing sarcoma is a type of cancer that forms in bone or soft tissue. The purpose of this study is to understand if adding the investigational medication improves event-free survival, which means the time patients live without the cancer getting worse.
Participants in this study will receive either multiagent chemotherapy alone or with an investigational medication. Chemotherapy is a treatment that uses powerful drugs to kill cancer cells or stop them from growing. The investigational medication is being tested to see if it can improve the effectiveness of the chemotherapy. Participants will be closely monitored throughout the study to assess treatment effects and any side effects.
- Who can participate: Patients eligible for this study must have a diagnosis of Ewing sarcoma or peripheral primitive neuroectodermal tumor with metastatic disease in areas such as the lung, bone, or bone marrow. They should not have received prior chemotherapy or radiation therapy, must agree to use effective contraception if of reproductive potential, and should not have pre-existing diabetes mellitus or be receiving chronic pharmacologic doses of corticosteroids.
- Study details: Participants will be assigned to receive either chemotherapy alone or with an investigational medication. The investigational medication is being tested and is not yet approved. A placebo is not used in this study. Participants will need to undergo regular monitoring to track the treatment's effects and any side effects.
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