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Brigitte Widemann, NCI, POB

SARC006: Phase II Trial of Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade Unresectable Malignant Peripheral Nerve Sheath Tumors. Brigitte Widemann, NCI, POB. Trial Schema. Eight chemotherapy courses total. IA x2. IE x2. NF1. MPNST. Local Control. Response

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Brigitte Widemann, NCI, POB

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  1. SARC006: Phase II Trial of Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade Unresectable Malignant Peripheral Nerve Sheath Tumors Brigitte Widemann, NCI, POB

  2. 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

  3. Patient Characteristics • Two patients enrolled: • Pt. 1: 24 y/o male with NF1 and metastatic MPNST • Toxicity: Tolerated chemotherapy well • Response evaluation post cy 4: Stable (WHO), 37% 3D • Complicated post surgery course, removed from protocol • Pt. 2: 21 y/o male with sporadic metastatic MPNST • Pt. presented with leukemoid reaction, and widespread metastases • Toxicity: Tolerated cy 1 of IA chemotherapy well (stable WHO) • Removed from protocol after cy. 1 for palliative radiation for pain control and due to delayed platelet recovery as a result of bone marrow involvement.

  4. SARC006 Protocol Status • Protocol (amendment #3) open for enrollment: • National Cancer Institute, Pennsylvania Oncology • NF1 Sites: • Close to approval: Children’s Memorial Chicago, Children’s Hospital and Clinics of Minnesota, Children’s Hospital of Philadelphia • In review/consideration: Cincinnati Children’s Hospital, Children’s Hospital of Pittsburgh, St. Louis Children’s Hospital, University of Alabama at Birmingham, Children’s National Medical Center

  5. SARC006 Protocol Status • SARC Sites: • Close to approval: University of Michigan, Texas Children’s Hospital, Dana Farber Cancer Institute • In review/consideration: University of Minnesota, MD Anderson, Mayo Clinic, Arkansas Children’s, Vanderbilt University, Emory University, Cleveland Clinic, Carolinas, Cedars Sinai, Lee Moffitt Cancer Center, Fox Chase Cancer Center, City of Hope, University of Utah, Stanford Comprehensive Cancer Center, Huntsman Cancer Center • Not participating: Washington Cancer Institute, MSKCC, Johns Hopkins, Seattle Cancer Care, UCLA, University of Florida, Sarcoma Oncology Center, Oregon Health and Science University

  6. SARC006 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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