Neoadjuvant Imatinib in DFSP SARC004 November 2008 update
SARC004: Pre-operative Imatinib in DFSP Objectives Determine effects of imatinib on phosphorylation of PDGFRB in DFSP Correlate inhibition of PDGFRB with: Plasma levels of imatinib Inhibition of downstream kinases Inhibition of tumor proliferation – Ki-67/MIB-1 Induction of apoptosis Bank patient matched tissue for future study
DFSP: Pre-operative Treatment Plan Pre-imatinib fresh tumor for molecular studies is required Imatinib 400 mg bid for 10 to 14 days prior to planned surgical resection Blood draw for imatinib plasma level within 24 hrs of surgery Collect tumor for study at surgery 15 evaluable patients (viable matched tumor tissue/subject taking imatinib)
Accrual by participating SARC sites MD Anderson 6 completed treatment; but 1 ineligible University of Michigan 5 completed study,1 screen failure University of Florida (closing) 1 completed study Pennsylvania Oncology – Open Moffitt 1 patient enrolled on 10/8/2008 13/15 enrolled – 1st patient enrolled 12/2006
SARC004: SAE Post-operative atypical chest pain Post-operative wound infection requiring intravenous antibiotics