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
About this trial
This is an expanded access trial for Ewing Sarcoma
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03029481
First Posted
January 20, 2017
Last Updated
March 26, 2019
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
NantCell, Inc.
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
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Primary Completion Date
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Study Completion Date
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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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