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Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
No longer available
CT.gov ID
NCT03029481
Collaborator
NantCell, Inc. (Industry)

Study Details

Study Description

Brief Summary

Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy options. A large body of preclinical data supports a role for IGF-1R inhibition in the treatment of Ewing sarcoma.

More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single- agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded access IND to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy options. A large body of preclinical data supports a role for IGF-1R inhibition in the treatment of Ewing sarcoma.

More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single- agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded access IND to provide our patient the opportunity to benefit from this treatment after having developed progressive disease after multiple lines of prior therapy.

Study Design

Study Type:
Expanded Access
Official Title:
Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    48 Years to 50 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    Diagnosis: Confirmed translocation-positive Ewing sarcoma

    Organ Function Requirements:

    Serum creatinine < 1.4 Adequate liver function

    • Total bilitubin <1.5x upper limit of normal for age

    • SGPT (ALT) < 5x upper limit of normal for age Adequate cardiac function > 50% by echocardiogram Bone Marrow

    • Absolute neutrophil count > 750

    • Platelet count > 75

    Exclusion Criteria:

    • 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 will be excluded from study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center
    • NantCell, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03029481
    Other Study ID Numbers:
    • 17-000019
    • JCCCID738
    First Posted:
    Jan 24, 2017
    Last Update Posted:
    Mar 28, 2019
    Last Verified:
    Mar 1, 2019
    Additional relevant MeSH terms:
    Sarcoma
    Sarcoma, Ewing

    Study Results

    No Results Posted as of Mar 28, 2019