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Trial record 6 of 265 for:    ewing sarcoma

Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma

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ClinicalTrials.gov Identifier: NCT03029481
Recruitment Status : Available
First Posted : January 24, 2017
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
NantCell, Inc.
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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
Ewing Sarcoma Drug: Ganitumab

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 Type : Expanded Access
  Individual Patient
  Treatment IND/Protocol
Official Title: Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma



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

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Ages Eligible for Study:   48 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029481


Contacts
Contact: Arun Singh, M.D. 310-586-2095 asingh@mednet.ucla.edu

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
NantCell, Inc.

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03029481     History of Changes
Other Study ID Numbers: 17-000019
JCCCID738 ( Other Identifier: Jonsson Comprehensive Cancer Center )
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs