Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor
Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
The investigational drug 5-ALA (known under the trade name Gliolan®) is an approved drug for
the surgical removal of malignant glioma (WHO grade III and IV). In this trial, the drug is
being tested outside of its actual approval as a radiosensitizer in combination with
conventional radiotherapy for first-time recurrence (relapse) of malignant glioma. In this
clinical trial, the investigational drug 5-ALA is being used for the first time in a multiple
dose escalation regimen in combination with radiotherapy following surgical removal of a
recurrent malignant glioma in humans. The investigational drug, 5-ALA, has been used as a
single dose to date as a standard of care for visualization of malignant tissue in the
surgical removal of gliomas.
The planned clinical trial will first and foremost investigate how well repeated
administration of the investigational drug 5-ALA is tolerated in combination with
radiotherapy. At the same time, the design of the trial serves to optimize this novel
therapeutic procedure with regard to the frequency of administration of the investigational
drug 5-ALA in combination with radiotherapy for future clinical trials.
As a secondary objective, the efficacy of additional 5-ALA administration will also be
investigated.