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A collaborative effort of: SARC: Trial coordination NCI: Principal investigators

Phase II Trial of Neoadjuvant Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade Unresectable Malignant Peripheral Nerve Sheath Tumors. A collaborative effort of: SARC: Trial coordination NCI: Principal investigators SARC institutions Selected NF1 centers

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A collaborative effort of: SARC: Trial coordination NCI: Principal investigators

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  1. Phase II Trial of Neoadjuvant Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade Unresectable Malignant Peripheral Nerve Sheath Tumors • A collaborative effort of: • SARC: Trial coordination • NCI: Principal investigators • SARC institutions • Selected NF1 centers • Funded through a Clinical Trial Award by the US Army DoD

  2. MPNST Trial Objectives • Primary objective: • Response rate (CR/PR, WHO criteria) after 4 cycles of neoadjuvant chemotherapy in NF1 and sporadic MPNST • Secondary objectives: • Response evaluation with 18FDG-PET and volumetric MRI • Correlate response by imaging studies with pathologic response • Molecular biology of MPNSTs , tissue microarray • Serum proteomics (compared to sera from pts with NF1 and plexiform neurofibromas) • Epidemiology of MPNSTs in NF1

  3. Trial Design IA x2 IE x2 NF1 • Eligibility:High grade unresectable MPNST MPNST Local Control Response Evaluation Chemotherapy IA x 2 IE x2 Sporadic Surgery XRT PET 3D MRI PET 3D MRI MRI • Statistical plan: • Simon optimal two-stage design (0.1 alpha/beta) • First stage 17 patients, go to second stage if 4+/17 respond • Chemotherapy active in strata if 11+/37 patients respond

  4. Treatment Schema

  5. Data Collection on Trial

  6. Protocol Status • NCI IRB and DoD approval obtained • Data forms developed by SARC • Informed consent has to receive institutional and US Army IRB approval prior to patient entry • Model informed consent with US Army requested elements was provided by SARC • SARC and NCI will assist in development and review of institutional informed consent

  7. DoD Requirements and Reimbursement Site / PI information required by DoD: • PI Assurance form • Facility Safety Plan • MPA or FWA number • PI most recent GCP training Planned reimbursement to sites: • IRB review/approval • $ 3500 / patient entered • $ 15 serum sample, $ 400 tumor processing/shipment • $ 100 CT/MRI, $ 200 PET (to ensure compliance with protocol)

  8. DoD Funded NF1 Consortium Operations Center Award: • University of Alabama at Birmingham Site Award recipients: • University of Alabama at Birmingham • Children’s Hospital Boston • Children’s Hospital of Philadelphia • Children’s National Medical Center, Washington, DC • Cincinnati Children’s Hospital Medical Center • National Cancer Institute, Bethesda, MD • University of Chicago • University of Utah • Washington University, St. Louis, MO

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