OncoMatch/Clinical Trials/NCT05590689
Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor
Is NCT05590689 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Gliolan for glioblastoma.
Treatment: Gliolan — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Allowed: MGMT methylation status (any)
independent of methylated MGMT promotor status when alkylating chemotherapy failed at this time
Prior therapy
Must have received: resection — initial
Recurrence of supratentorial glioblastoma after initial resection and adjuvant therapy
Must have received: adjuvant therapy — initial
Recurrence of supratentorial glioblastoma after initial resection and adjuvant therapy (e.g. radio-chemotherapy, targeted therapies, antiangiogenic therapies as determined by the tumor board)
Cannot have received: potentially phototoxic or photosensitizing substances (tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts, products containing St. John's wort)
Pre-treatment with other potentially phototoxic or photosensitizing substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts, products containing St. John's wort ) during the 2 weeks preceding RDT
Lab requirements
Blood counts
Blood clotting: INR/Quick/PT and PTT within acceptable limits according to the investigator
Kidney function
creatinine < 3x ULN; eGFR >= 60 ml/min
Liver function
bilirubin < 1.5x ULN (or < 3x ULN with Gilbert's disease); ALT/SGPT and AST/SGOT < 3x ULN
Adequate liver function: bilirubin < 1.5 times above upper limit of normal range (ULN), alanine transaminase (ALT/SGPT) and aspartate transaminase (AST/SGOT) < 3 times ULN. In the case of documented or suspected Gilbert's disease bilirubin < 3 times ULN. Adequate renal function: creatinine < 3 times above ULN; eGFR >= 60 ml/min, Blood clotting: INR/Quick/PT and PTT within acceptable limits according to the investigator.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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