Status:
WITHDRAWN
A Phase I Study of IMC-A12 in Combination With Temsirolimus in Pediatric Patients With Recurrent or Refractory Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Brain Stem Neoplasms
Glioma
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief Summary
Background: \- IMC-A12 is an experimental substance designed to inhibit a protein called Type I Insulin-Like Growth Factor Receptor (IGF-1R), which can be found on cancer cells and can promote cancer...
Detailed Description
Background * IMC-A12 is a fully recombinant IgG1monoclonal antibody to the insulin-like growth factor receptor (IGFR). It acts as an antagonist of IGF-1 and IGF-2 ligand binding and blocks ligand bin...
Eligibility Criteria
Inclusion
- Eligibility
- Patients \> 12 months and less than or equal to 21 years of age with a diagnosis and histologic verification (except patients with intrinsic brain stem tumors, optic pathway gliomas or pineal tumors and elevations of serum or CSF alpha-fetoprotein or beta-HCG) of measureable or evaluable relapsed or refractory solid tumors. Current disease state must be one for which there is no known curative therapy, or therapy proven to prolong survival.
- Must have fully recovered from acute toxic effects from all prior therapy, which has been completed within the specified prior time frame.
- Have adequate organ function as determined by laboratory evaluation including normal random or fasting blood glucose within the upper normal limits for age and grade \< 2 serum cholesterol and triglyceride levels.
- Subjects with uncontrolled infection, known type I or type II diabetes mellitus, known bone marrow involvement or who have received prior monoclonal antibody therapy targeting IGF-1R or temsirolimus are not eligible.
Exclusion
Key Trial Info
Start Date :
July 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01182883
Start Date
July 28 2010
End Date
April 4 2012
Last Update
July 2 2017
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