NCT05590689

Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor

Phase I/II Dose Escalation Trial of Radiodynamic Therapy (RDT) With 5-Aminolevulinic Acid in Patients With First Recurrence of Glioblastoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Universität Münster · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Gliolan	A repetitive dose of Gliolan will be administrated in combination with radiotherapy (radiodynamic therapy)
RADIATION	Radiodynamic therapy	Radiotherapy will be performed in combination with Gliolan administration

Timeline

• Start date: 2022-11-09
• Primary completion: 2026-06-01
• Completion: 2027-01-01
• First posted: 2022-10-21
• Last updated: 2024-12-16

Locations

1 site across 1 country: Germany