Patients with glioblastoma at first or second progression who have failed standard treatment that must have included radiochemotherapy with temozolomide and who are a candidate for a reirradiation can be included into the trial. In the phase I part the minimal tolerated dose (MTD)of BIBF 1120 in combination with radiotherapy will be investigated. Subjects in phase II will be randomised to receive reirradiation alone or reirradiation + 2 x MTD BIBF1120.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
BIBF 1120 is given as 2 x minimal tolerated dose per day as long as as a clinical benefit is considered by the treating physician.
36 Gy, 2 Gy / fraction, 18 fractions
University Hospital Heidelberg, Department of Neurooncology
Heidelberg, Baden-Wurttemberg, Germany
University Hospital Heidelberg, Department of Pharmacology
Heidelberg, Baden-Wurttemberg, Germany
Maximal tolerated dose of BIBF 1120 in combination with reirradiation (Phase I)
Time frame: day 0, 8, 15 and 17 post-dose during phase I
Number of participants with adverse events as a measure of safety and tolerability of BIBF1120
Time frame: Up to 90 days follow-up
Progression-free survival
Time frame: Time from randomization until death or disease progression
Objective response rates (OR)
Time frame: Time from randomization until response
Overall survival
Time frame: Time from randomization until death
Quality of life as determined by EORTC QLQ-C15 PAL and the EORTC brain module QLQ-BN 20
Time frame: Screening and 6-weekly after radiotherapy
Cognitive function determined by MMSE
Time frame: Screening and 6-weekly after end of radiotherapy
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