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Research and Clinical Trials

Brief Description  
The purpose of this study is to find out what effects, good and/or bad, the drugs IMC-A12 and temsirolimus have on metastatic sarcoma. IMC-A12 is an investigational drug and is not yet approved by the Food and Drug Administration (FDA) except for use in this study. Temsirolimus is FDA approved for use in the U.S. for kidney cancer. Temsirolimus is not FDA approved for treatment of sarcomas in the U.S. but early studies have shown that it may help some patients with sarcoma. Eligible patients wil
Who may be Eligible  

Key eligibility
  1. Patients must have histologically or cytologically confirmed sarcoma of bone.
  2. Subjects must have metastatic and/or locally advanced or locally recurrent disease.
  3. Patients must have measurable disease by RECIST 1.1.
  4. A minimum of 1 and a maximum of 4 prior systemic therapy regimens for recurrent/metastatic disease. The last dose of systemic therapy must have been given at least 4 weeks prior to initiation of therapy.
  5. Patients with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months following the procedure with no neurological signs or symptoms and no requirement for systemic glucocorticoids are eligible for study.
  6. Age >18 years.
  7. ECOG performance status 0 or 1.
  8. Patients must have normal organ and marrow function.
  9. Patients must not have current evidence of another malignancy.
  10. Patients may not have received prior IGFR1 inhibitors or mTOR inhibitors.
  11. Patients with hyperglycemia, defined as fasting serum glucose above 120 mg/dl, or those patients already on oral anti-diabetic or insulin therapy are excluded.
Speciality/Disorder  
Sarcoma
IRB Number  
02-10-15B
Principal Investigator  
Livingston, Michael

For More Information, Contact  Allison  L, Gruntz
Phone:  (704) 446-1921  Fax:  (704) 355-1352  
Email:  allison.gruntz@carolinashealthcare.org
Address:1100 South Tryon Street Suite 220 Charlotte, NC 28203
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