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Neoadjuvant Imatinib in DFSP SARC 004 University of Michigan coordinating center.

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Presentation on theme: "Neoadjuvant Imatinib in DFSP SARC 004 University of Michigan coordinating center."— Presentation transcript:

1 Neoadjuvant Imatinib in DFSP SARC 004 University of Michigan coordinating center

2 SARC study: pre-operative imatinib in newly diagnosed DFSP Objectives: Determine effects of imatinib on phosphorylation of PDGFRB in DFSP Correlate inhibition of PDGFRB with: –plasma and tissue levels of imatinib –Inhibition of downstream kinases –Inhibition of tumor proliferation – Ki-67 –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 DFSP:logistics Pre-imatinib fresh/frozen tumor required Imatinib-treated fresh/frozen tumor required CBC at day 7-10 required (safety) Blood sample for imatinib level at time of surgery required Gleevec supplied by SARC Paper case report forms SARC pay for pre-treatment biopsy

5 Eligibility DFSP Surgery to resect mass planned Gross disease ANC > 1,500, PLT > 100,000, bilirubin 1,500, PLT > 100,000, bilirubin < 1.5x ULN ECOG 0,1 or 2 No prior radiation to site No chemotherapy within 4 weeks Negative pregnancy test for women not amenorrheic > 12 months

6 Implementation timeline Activated at UM October 2005 Under review at MD Anderson, University of Washington, Memorial, Dana-Farber, Moffitt, Pennsylvania, Washington


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