Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma

Ewing Sarcoma Clinical Trial

Official title:

Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03029481
• Other study ID #: 17-000019
• Secondary ID: JCCCID738
• Status: No longer available

Study information

• Verified date: March 2019
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 48 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ewing Sarcoma
• Sarcoma
• Sarcoma, Ewing

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	NantCell, Inc.