Early Clinical Trials (Phase I/II Trials) in Paediatric Oncology

Editor:  Julia Dobke, English Translation:  Dr. med. Gesche Riabowol (nee Tallen), Last modification: 2024/10/25 https://kinderkrebsinfo.de/doi/e5127

For children and adolescents with high-risk, relapsed or refractory malignant diseases in particular, curative approaches for second-line therapy are limited. For these groups of patients, enrollment in early clinical trials (phase I or II trials) can be an option for cure or increased lifespan, or, at least, help reduce the side effects of treatment.

In order to help patients and doctors find information on recruiting early clinical trials, the German Society for Paediatric Oncology and Hematology (GPOH) has established five trial networks. The GPOH‘s goal is

  1. to provide access to innovative therapies for children and adolescents with an oncological disease nationwide and
  2. to provide an infrastructure that meets the high technological and administrative requirements of conducting multicentre phase I/II trials.

So far, this network structure has been

  • expanding the portfolio for phase I/II studies for children and adolescents with cancer in Germany,
  • improving patient access to open phase I/II trials locally,
  • informing health care workers, patients and families (parents) about currently open phase I/II trials,
  • optimising the alignment of studies with rare biomarker-defined inclusion criteria
  • increasing the quality of conducting early clinical trials in paediatric oncology,
  • enriching the scientific understanding of recurrent or high-risk disease in children and adolescents with cancer.

Patients and physicians can use the links or contact addresses listed below to find out about the currently open phase I/II studies in the networks. For the planning of new studies, sponsors can quickly request information on suitable study sites and case numbers via the network chairs/principal investigators.

Clinical trial networks of the GPOH e.V.
Within Germany, five regional trial networks have been founded to provide information about the range of courses offered by the regional treatment centres.