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Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma

Primary Purpose

Ewing Sarcoma

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Ganitumab
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Ewing Sarcoma

Eligibility Criteria

48 Years - 50 Years (Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 20, 2017
    Last Updated
    March 26, 2019
    Sponsor
    Jonsson Comprehensive Cancer Center
    Collaborators
    NantCell, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03029481
    Brief Title
    Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma
    Official Title
    Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jonsson Comprehensive Cancer Center
    Collaborators
    NantCell, Inc.

    4. Oversight

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ewing Sarcoma

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Ganitumab
    Other Intervention Name(s)
    AMG 479
    Intervention Description
    The patient will receive ganitumab, 18 mg/kg/dose intravenously every 2 weeks until clinical progression or decision to move to an alternate therapy.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    48 Years
    Maximum Age & Unit of Time
    50 Years
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma

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