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  • A Phase II Study of Hyperfractionated Stereotactic Radiotherapy in the Treatment of Metastatic Pediatric Sarcomas of Bony Sites Rochester, Minn.

    The SBRT (stereotactic body radiation therapy) literature focuses on clinical outcomes in the adult population. However, SBRT (stereotactic body radiation therapy) has a particularly strong rationale for application in pediatrics given that high biologically effective doses have been shown to increase control in histologies, such as sarcoma, which are common in the pediatrics population (11,25). With stereotactic radiation therapy techniques, a reduction in normal tissue dose surrounding the target lesion of interest may also be accomplished resulting in lower toxicity. Given that pediatric patients with sarcomas, presenting with limited metastases in lung and bone, are still considered to be a curable population with aggressive local therapy, SBRT could have a significant impact on outcomes in oligometastatic patients who may be otherwise unresectable (25-28).

  • A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma Rochester, Minn.

    This randomized phase III trial studies combination chemotherapy to see how well it works compared to combination chemotherapy with topotecan hydrochloride in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.

  • A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease Scottsdale/Phoenix, Ariz., Rochester, Minn.

    RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether stereotactic radiosurgery is more effective than whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.

    PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works compared to whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.

  • A Pilot Study Evaluating the Utility of 18F-DOPA PET for Radiotherapy Treatment Planning of Malignant Glioma Patients Rochester, Minn.

    For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used to image the tumor and guide your radiation oncologist in determining locations to treat with radiation. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most aggressive regions of the tumor. The goal of this study is to use the 18F-DOPA PET/CT scan to help determine where the disease is that needs to be treated with radiation, in order to improve the effectiveness of radiation in this tumor.

  • A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases Mankato, Minn., La Crosse, Wis., Eau Claire, Wis., Rochester, Minn., Albert Lea, Minn.

    This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help limit the radiation-induced cognitive decline. It is not yet known whether giving memantine hydrochloride and WBRT with or without hippocampal avoidance works better in reducing neurocognitive decline in patients with brain metastases.

  • AEWS1221, Randomized Phase II Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008) to Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma (AEWS1221) Rochester, Minn.

    This randomized phase II trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Monoclonal antibodies, such as ganitumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination chemotherapy is more effective with or without ganitumab in treating patients with newly diagnosed Ewing sarcoma.

  • Early Evaluation of Cardiac Toxicity Following Radiotherapy Rochester, Minn.

    The purpose of this study is to determine if stress cardiac magnetic resonance imaging (MRI) imaging will allow us to detect radiation-related cardiac toxicity before other evaluation modalities would allow.

  • Evaluation of Cognitive-Communication Deficits Following Treatment of Primary Brain Tumor Patients Rochester, Minn.

    This study is to evaluate which cognitive-linguistic symptoms are most commonly experienced following brain tumor treatment. Cognitive surveys will be administered after treatment of primary brain tumor cancer.

  • MC1373 Evaluating the Impact of 18F-DOPA-PET on Neurosurgical Planning for Gliomas Rochester, Minn., Scottsdale/Phoenix, Ariz.

    This pilot clinical trial studies fluorine F 18 fluorodopa (18F-DOPA)-positron emission tomography (PET) in planning surgery in patients with gliomas. New imaging procedures, such as 18F-DOPA-PET scan, may help find gliomas and may help in planning surgery.

  • MC167B: Pilot Study Investigating the Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma Rochester, Minn.

    This proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast enhancement and T2 FLAIR on MRI. We then plan to compare patterns of failure with target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.

  • MC1774, Phase II Study of Short Course Hypofractionated Proton Beam Therapy Incorporating 18F-DOPA-PET/MRI for Elderly Patients with Newly Diagnosed Glioblastoma Scottsdale/Phoenix, Ariz., Rochester, Minn.

    The purpose of this study is to utilize a novel approach of combining advanced radiation delivery with proton beam therapy with advanced tumor visualization with 18F-DOPA PET and MRI imaging. We will study the effectiveness and safety of this technique delivering the entire treatment over 1-2 weeks.

  • Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control in Patients with Supratentorial Low-Risk Grade II Glioma Rochester, Minn., Scottsdale/Phoenix, Ariz.

    This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Learning about brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery may help doctors learn more about the disease and find better methods of treatment and on-going care.

  • Utility of Gallium-68-DOTA-Octreotat PET/CT in the Characterization of Pediatric Neuroendocrine Tumors Rochester, Minn.

    The purpose of this pilot study is to assess the efficacy of the Federal Drug Administration approved 68Ga-DOTATATE PET/CT in the radiotherapeutic target volume definition of metastatic neuroendocrine tumors as compared to MIBG scintigraphy. Secondary

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