ANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors
All pediatric patients (aged 1-16 yrs) with newly diagnosed diffuse brain stem tumor or
inoperable thalamic tumor which infiltrate brain stem from the pediatric oncology units in
Denmark, Finland, Iceland, Norway and Sweden will be eligible. A possible tumor biopsy with
histologic findings is not taken into account. The diagnosis is based on MRI. The patients
are given a conventional local radiotherapy of 54 Gy, during which the patient also receives
topotecan as radiosensitizer. Within four weeks after completed radiotherapy, the
investigational drugs are started. If the family for some reason refuses radiotherapy, the
investigational therapy may still be considered. The guardians and age-appropriate patients
are asked for written informed consent. If the family is not willing to participate in the
trial, the patient is treated according to the currently best available therapy (meaning RT
without topotecan as palliative therapy). The family has the right to withdraw from the
study, whenever they so wish.
Brain MRI at initial diagnosis, before the start of triple medication, and q 3 mo after
initiation of triple medication, if not otherwise clinically indicated. In case it is
decided to continue medication with progression in MRI, repeat MRIs are recommended every
month. MRI should also be registered, if feasible, at the discontinuation of the medication.
The clinical follow-up, as well as MRI follow-up, on clinical indications will continue also
after discontinuation of therapy.
PET-CT and/or MRI spectroscopy should be considered at diagnosis and at 3 mo after the start
of triple medication.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome measure is survival in months.
up to five years
Sanna-Maria Kivivuori, md
Helsinki University Central Hospital
Finland: Finnish Medicines Agency