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Phase II Trial of Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade Malignant Peripheral Ne

SARC 006. Phase II Trial of Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade Malignant Peripheral Nerve Sheath Tumors. Brigitte Widemann, NCI, POB. SARC006 Study Objectives. Primary Objective Determine clinical response rate (WHO)

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Phase II Trial of Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade Malignant Peripheral Ne

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  1. SARC 006 Phase II Trial of Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade Malignant Peripheral Nerve Sheath Tumors Brigitte Widemann, NCI, POB

  2. SARC006 Study Objectives • Primary Objective • Determine clinical response rate (WHO) • High grade, unresectable, or metastatic, potentially resectable sporadic and NFI associated MPNST for which neoadjuvant chemotherapy is determined to be the best treatment option by institutional PI • Secondary Objectives • Imaging (PET/Volumetric MRI analysis) • Pathology (Percent necrosis; tissue microarray) • Biomarker • Improve knowledge of NF1 epidemiology

  3. Trial Schema *Eight chemotherapy courses total IA x2 IE x2 NF1 MPNST Local Control Response Evaluation Chemotherapy IA x 2 IE x2 Sporadic PET 3D MRI Surgery XRT PET 3D MRI MRI

  4. Patient Eligibility • Sporadic or NF1 associated MPNST • Unresectable; metastatic; potentially resectable but neoadjuvant chemotherapy is determined to be in the best patient interest • Not previously treated with chemotherapy; prior radiation permitted • No upper or lower age limit • ECOG 0-2 • Normal organ function • Cardiac (MUGA or Echo) • Renal, liver and bone marrow • Prior treatment with biologic agents or chemotherapy for other NF1 associated tumors permitted • No prior ifosfamide, etoposide or doxorubicin

  5. Trial Status • Patients enrolled: 12 • NF1 associated MPNST 8 pts; sporadic MPNST 3 pts • Median age 29.5 years (range 21-67 years) • Disease status: • Localized 7 pts; metastatic: 5 pts • On study 7 pts, off study 5 pts • SAEs (possibly, probably, or definitely related): • One pt: Ifosfamide related aphasia (gr. 4), somnolence (gr. 4) • One pt: Anemia, dyspnea, and fatigue (gr. 3), orthostatic hypotension (gr. 2) • One pt: Urinary tract infection (gr. 3) • One pt: Leukopenia (gr. 4) and fever (gr. 1)

  6. Response Evaluation NF1 MPNST Nine patients enrolled

  7. Response Evaluation Sporadic MPNST Three patients enrolled

  8. SARC 006 Protocol Status • SARC Sites:

  9. SARC 006 Protocol Status • SARC Sites: • Not participating: City of Hope, Dana-Farber, Fox Chase, Johns Hopkins, Moffitt, MSKCC, Oregon Health and Science University, Sarcoma Oncology Center, Stanford, Seattle Care Alliance, UCLA, University of Florida, Washington Cancer Institute

  10. SARC 006 Protocol Status • NF1 Sites:

  11. SARC 006 Approval Process • Contract with SARC • Institutional protocol review • US Army IRB review: • Informed consent form, assent (ages 13-17 years) form, and information page (ages 7-12 years old), site specific protocol appendices • CV for all investigators • Facility safety plan • PI assurance plan • GCP training for PI • US Army will perform pre-review of documents prior to local IRB submission • All communication with US Army IRB through SARC

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