Translational Trial Group
The Translational Trial Group of the KiTZ Clinical Trial Unit translates the latest research findings - including results from the preclinical program of the KiTZ - into an innovative treatment concept. This multidisciplinary team of specialized physicians and trial managers, working together closely with the Department of Biostatistics of the DKFZ and the NCT Trial Center, develops innovative international study protocols and coordinates its own phase I-III academic studies with sites in and outside Europe. The main focus is on biomarker driven trials and targeted/immune therapies using new drugs and rationale combinations. Examples of the two main current activities (INFORM2 trial series and the LOGGIC project) can be found below.
The group is embedded in several international networks. ITCC (Innovative Therapy for Children with Cancer) is a network of pediatric phase I/II sites and an important partner for academia and pharmaceutical industry for the roll out of pediatric early phase clinical trials. KiTZ has received ITCC international sponsor and national coordination accreditation in 2018, enabling the Translational Trial Group to roll out its own academic trials over the large ITCC network under its own governance. Furthermore, strong collaborations exist with other clinical trial groups in Germany (Society for Pediatric Oncology and Hematology (GPOH)), Europe, North-America (St. Jude and CONNECT) and Australia. Also, strong collaborations with the pharmaceutical industry guarantee access to new innovative drugs.
Importantly, the Translational Trial Group also builds partnerships with investigators performing clinical trials in adult oncology, e.g. in the NCT.
INFORM2 (Individualized therapy For Relapsed Malignancies in childhood) translates the molecular findings of the INFORM Registry (the international next-generation diagnostics platform for progressive/relapsed malignancies) into biomarker driven phase I-II trials with new targeted/immune therapies and combinations. The first trial (funded by German Cancer Aid) will open early 2019 and further trials are in preparation, all based on new preclinical data and the availability of new (targeted) drugs. The INFORM2 trial includes trial sites in several European countries and Australia.
The LOGGIC (LOw Grade Glioma In Children) project (funded by “Brain Tumor Charity” and “PLGA foundation”) consist of the LOGGIC Core BioClinical Data Bank (LOGGIC Core) and the LOGGIC Europe Trial. LOGGIC Core is a platform providing molecular testing to all newly diagnosed patients with a low grade glioma (LGG). The LOGGIC Europe trial is a phase III trial randomizing chemotherapy (vincristine and carboplatin combination or weekly vinblastine) against targeted therapy with an oral MEK inhibitor (trametinib) for all patients who need further treatment after initial operation. The LOGGIC Europe trial will include sites in most European countries, but also in some countries outside Europe, e.g. Australia.
Since tumors of all patients, including those who received further treatment within the LOGGIC Europe Trial, were fully molecular characterized via the upfront LOGGIC Core platform, the program will provide a deep molecular understanding of the disease and its treatment.