HIT-MED Trial office

  • After leukemia, brain tumors are the second most frequent malignant disease in children and adolescents. There are approximately 400 patients diagnosed with a brain tumor every year. Although the chance of cure has increased during the last years significantly and today approximately 80% of the patients can expect long-term survival after diagnosis of a brain tumor in childhood, the results of current therapy are not satisfactory. While the survival still needs to be improved, at the same time the long-term side effects of both the disease and the treatment need to be improved.On behalf of the society for pediatric hematology and oncology (Gesellschaft für Pädiatrische Onkologie und Hämatologie, GPOH), the HIT-MED trial office coordinates clinical research projects on medulloblastoma, ependymoma and different other malignant, very rare brain tumors of childhood and adolescence.The HIT-MED trial office, we dedicate our work to

    • the development and optimization of treatment concepts (operation, radiotherapy, chemotherapy) for patients with these brain tumors
    • the development and maintenance of systems for central reference centers for children with brain tumors.
    • counselling of physicians in participating centers in the treatment of the above mentioned brain tumors.

    The HIT-MED trial office coordinates several clinical research projects:

    HIT2000

    PNET5

    I-HIT-MED Registry

    Neuropsychological co-study

    The German Reference Centre for CSF diagnostics is also located at the university medical centre in Hamburg:
    German Reference Centre CSF diagnostics

    The HIT-MED trial office receives funding from the German childhood cancer foundation (www.kinderkrebsstiftung.de ), the "Fördergemeinschaft Kinderkrebs-Zentrum Hamburg e.V." (www.kinderkrebs-hamburg.de ) and the Damp-Foundation (www.damp-stiftung.de).

  • Not all patients with brain tumors can be included into clinical trials for various reasons. Either because such a trial is not available in the hospital the patient or his representatives have chosen or because patients prefer standard treatment. However, many of these patients are open to participate in research activities. Therefore, the HIT-MED trial office has opened an international registry for patients with

    • Medulloblastoma
    • Ependymoma
    • CNS-PNET including
      • Ependymoblastoma
      • CNS ganglineuroblastoma
      • CNS neuroblastoma
      • Medulloepitelioma
    • Pineoblastoma
    • Pineal parenchymal tumour of intermediate differentiation and
    • Papillary tumour of the pineal region.
    Patients of any age can be registered in the I-HIT-MED registry with the aim to collect both clinical data and biological data and analyse these with the aim to increase our knowledge on the effects of therapy and tumor biology.
    Moreover, the I-HIT-MED registry database will help us when counselling physicians in how to select the optimal treatment for their patients.

  • PNET5

    PNET5 is a prospective multicenter phase II/III clinical trial to optimize the therapy for non-metastatic standard risk medulloblastoma in children, adolescents and young adults with medulloblastoma. To be included, patients need to be older than 3 or 5 years, depending on histological medulloblastoma subtype.
    Stefan Rutkoswki, Hamburg, Germany and François Doz, Paris, France are principal investigators of this trial, the sponsorship has been taken over by the University Medical Center Hamburg Eppendorf, Hamburg, Germany. The study aims at recruiting 360 patients in 16 European countries during the 5 year enrolment period and more partnering countries are likely to join the trial consortium.
    PNET5 is designed to answer two main questions:

    • Is it safe to reduce the intensity of therapy in patients with low-risk medulloblastoma, as measured by the rate of relapse-free survival?
    • Does carboplatin given simultaneously to the postoperative radiotherapy increase the relapse-free survival compared to radiotherapy alone?

    As secondary objective, questions on tumor biology and various late effects (e.g. quality of survival, neuropsychological follow-up) will be addressed.

    EudraCTNr: 2011-004868-30
    ClinicalTrials.gov ID: NCT02066220

  • HIT2000 and PNET4

    HIT2000 was a multicentric clinical trail for children, adolescents and young adults with medulloblastoma, ependymoma or CNS-PNET. PNET4 was an international arm of HIT2000 for patients older than 4 with localized medulloblastoma.
    HIT2000 was open from Jan 1st, 2001 to Dez 31st, 2011 in up to eight European countries. More than 150 pediatric oncology centers registered more than 1300 patients in that period into one of the nine treatment strata. Besides the impact of other unifying international activities, HIT2000/PNET4 was a further step into the current fruitful European collaborations in brain tumor research.
    The different treatment strata of HIT2000 are currently in different stages of evaluation. While for some arms, results have been published, others still need to be evaluated within the next years.

    Selection of publications from HIT2000:
    Rutkowski S, Gerber NU, von Hoff K, Gnekow A, Bode U, Graf N, et al. Treatment of early childhood medulloblastoma by postoperative chemotherapy and deferred radiotherapy. Neuro Oncol 2009;11(2):201-10.

    Lannering B, Rutkowski S, Doz F, Pizer B, Gustafsson G, Navajas A, et al. Hyperfractionated versus conventional radiotherapy followed by chemotherapy in standard-risk medulloblastoma: results from the randomized multicenter HIT-SIOP PNET 4 trial. J Clin Oncol 2012;30(26):3187-93.

    Lannering B, Rutkowski S, Doz F. HIT-SIOP PNET-4 - A randomised multicentre study of hyperfractionated (HFRT) versus standard radiotherapy (STRT) in children with standard risk medulloblastoma. Neuro Oncol 2010;12(6):ii5.

    Friedrich C, von Bueren AO, von Hoff K, Kwiecien R, Pietsch T, Warmuth-Metz M, et al. Treatment of adult nonmetastatic medulloblastoma patients according to the paediatric HIT 2000 protocol: a prospective observational multicentre study. Eur J Cancer 2013;49(4):893-903.

    Friedrich C, von Bueren AO, von Hoff K, Gerber NU, Ottensmeier H, Deinlein F, et al. Treatment of young children with CNS-primitive neuroectodermal tumors/pineoblastomas in the prospective multicenter trial HIT 2000 using different chemotherapy regimens and radiotherapy. Neuro Oncol 2013;15(2):224-34.

    Friedrich C, Muller K, von Hoff K, Kwiecien R, Pietsch T, Warmuth-Metz M, et al. Adults with CNS primitive neuroectodermal tumors/pineoblastomas: results of multimodal treatment according to the pediatric HIT 2000 protocol. J Neurooncol 2014;116(3):567-75.

  • Neuropsychological co-study

    Within the neuropsychological co-study, patients with medulloblastoma, ependymoma and CNS-PNET receive neuropsychological assessments if they were between 0 and 21 years at diagnosis and were registered to one of the clinical trials or clinical registered organized by the HIT-MED trial office. The assessments include tests for problems with concentration, fine motor skills or memory. The results are combined with the clinical data obtained during the treatment course and analyzed systematically in order to quantify post-treatment neuropsychological outcome of the patients and to identify potential risk factors that have influence on the outcome.

    Additionally, patients and their families receive a detailed report on their test results. This results includes recommendations on how to improve school / professional and everyday reintegration and discusses options on where to find further support, if necessary.

  • German Reference Centre CSF-cytology

    Since 2009, the German Reference Centre CSF-cytology is located at the University Medical Centre Hamburg-Eppendorf. Since 2014, it is led by Prof. Dr. med. C. Hagel, department of Neuropathology.

    The German Reference Centre for CSF-cytology evaluates the CSF-cytology of children diagnosed with malignant brain tumors, with the aim to improve the diagnostic quality by an independent review of local results.

    The results obtained by the German Reference Centre for CSF-diagnostics are also used in a variety of clinical trials for children with malignant brain tumor.

    Contact:
    German Reference Centre for CSF-cytology
    Institut für Neuropathologie
    Prof. Dr. med. C. Hagel
    Haus O50
    Martinistraße 52
    20246 Hamburg

    FAX: 040-7410-54929

  • Contact: HIT MED trial office

    Postal address:
    University medical center Hamburg-Eppendorf
    Department for pediatric hematology and oncology
    Martinistraße 52
    20246 Hamburg
    Germany

    Coordinator:
    Stefan Rutkowski, MD
    Professor of pediatric oncology
    s.rutkowski@uke.de
    Phone: +49 (0) 40 7410 - 54270

    Deputy coordinator:
    Katja von Hoff, MD
    k.von-hoff@uke.de
    Phone: +49 (0) 40 7410 - 53394

    Trial physician:
    Martin Mynarek, MD
    m.mynarek@uke.de
    Phone: +49 (0) 40 7410 - 53394

    Trial management:
    Regine Riechers
    r.riechers@uke.de
    Phone: +49 (0) 40 7410 - 56776
    Fax: +49 (0) 40 7410 - 58300

    Documentation:
    Susanne Becker
    Antje Stiegmann
    hitchem@uke.de
    Phone: +49 40 7410-58200
    Fax: +49 40 7410-58300

    Neuropsyhological co-study
    Julia Kastenbauer
    j.kastenbauer@uke.de
    Phone: +49 (0) 40 7410 - 56222
    Fax: +49 (0) 40 7410 - 58300

    German reference centre for CSF-cytology
    University medical Centre Hamburg Eppendof
    Institute for neuropathology
    Prof. Dr. med. C. Hagel
    Haus O50
    Martinistraße 52
    20246 Hamburg
    Germany

    FAX: +49 (0) 40 7410 - 54929
    Tel.: +49 (0) 40 7410 - 53222