EWS1221: Phase II Study of Ganitumab with Chemotherapy for Patients with Metastatic Ewing Sarcoma

Randomized 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

Category:

Solid Tumor

Diseases Treated:

Ewing sarcoma

Eligibility Overview:

  • Younger than or equal to 50 years old
  • Diagnosis of 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
  1. Brief Summary

    Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with newly diagnosed metastatic Ewing sarcoma continue to have poor outcomes when treated with standard multiagent chemotherapy. New lines of research have found that the insulin-like growth factor receptor-1 (IGF-1R) may play a role in more effective treatment for this disease. Several studies have demonstrated that treatment with an IGF-1R inhibitor increases the sensitivity of Ewing sarcoma cells to the effects of chemotherapy.

    Ganitumab is a fully human monoclonal antibody directed against IGF-1R. This phase II randomized trial will study the effectiveness of combination chemotherapy with or without ganitumab for patients with newly diagnosed, metastatic Ewing sarcoma.

    Primary Objective

    • To compare the event-free survival in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab (AMG 479)

    Eligibility Criteria

    Inclusion criteria include:

    • Younger than or equal to 50 years old
    • Diagnosis of 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
    • Adequate renal function
    • Biopsy of the primary tumor without an attempt at complete or partial resection (Patient will still be eligible if excision was attempted or accomplished as long as adequate anatomic imaging was obtained prior to surgery.)

    Exclusion criteria include:

    • Regional node involvement as the only site of disease beyond the primary tumor
    • Primary tumors arising in the intra-dural soft tissue
    • Prior chemotherapy or radiation therapy
    • Female of childbearing potential or pregnant
    • Pre-existing diabetes mellitus

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

    Collaborating sites in and outside the U.S.

  2. About this Clinical Trial

    Ewing sarcoma is a cancer that grows in the bones or in the tissue around the bones, called soft tissue. It is the second most common type of pediatric bone cancer. Treatment usually includes chemotherapy drugs to fight the cancer, surgery to remove the tumor and/or radiation therapy to treat the tumor.

    Ewing sarcoma can spread to the lungs, bones and bone marrow. When this happens, it is called metastatic Ewing sarcoma. This type of cancer is harder to treat and may not respond well to the same type of chemotherapy drugs used to treat cancer that has not spread. 

    Researchers have conducted many studies to try to find better treatments for Ewing sarcoma that has spread. Some research suggests a new experimental drug, called ganitumab, may help chemotherapy drugs work better. 

    Ganitumab is an antibody designed to stop a protein called Insulin-Like Growth Factor-1 Receptor, also known as IGF-1R. The body’s immune system uses antibodies to fight diseased or foreign cells. IGF-1R is a molecule that is usually found on Ewing sarcoma cells. It can encourage cancer cells to grow. If ganitumab can block IGF-1R, it may prevent the cancer cells from growing.

    Some laboratory studies have shown ganitumab may work against Ewing sarcoma and some other types of childhood cancer. Ganitumab has been given to adults with cancer, including Ewing sarcoma. It has not been given to children with cancer. Ganitumab has not been approved by the Food and Drug Administration to treat Ewing sarcoma. 

    Purpose of this Clinical Trial

    The main goal of this study is to find out the good and bad effects of combining standard chemotherapy drugs with ganitumab in children and young adults with Ewing sarcoma that has spread to other parts of the body.

    Eligibility Overview

    • Younger than or equal to 50 years old
    • Diagnosis of 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
  3. EWS1221 Quick View
    Sponsors National Cancer Institute
    ClinicalTrials.gov identifier NCT92396161
    Trial start date December 2014
    Estimated enrollment 140
    Study type Interventional
    Study phase Phase II
    Conditions Metastatic Ewing sarcoma
    Ages Younger than or equal to 50 years old
    Principal investigator Sara Federico, MD
    Study sites St. Jude Children's Research Hospital and collaborating sites in and outside the U.S.
    For a consultation or to discuss EWS1221 St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Sara Federico, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

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