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Neoadjuvant Imatinib in DFSP

Neoadjuvant Imatinib in DFSP. SARC 004 October 2007 update. SARC 004: 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

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Neoadjuvant Imatinib in DFSP

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  1. Neoadjuvant Imatinibin DFSP SARC 004 October 2007 update

  2. SARC 004: 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

  3. DFSP: Pre-operative Treatment Plan • Biopsy to establish diagnosis, obtain pre-imatinib fresh tumor for molecular studies • 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)

  4. Accrual by participating SARC sites • MD Anderson • 5 consented • 4 competed treatment • University of Michigan • 4 consented, 1 screen failure • 3 completed study • University of Florida • 1 completed study • Pennsylvania Oncology – open • Moffitt – protocol at IRB • 9/15 enrolled – 1st patient enrolled 12/2006

  5. SARC 004: SAE • Post-operative atypical chest pain • Post-operative wound infection requiring intravenous antibiotics

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