Actively Recruiting
Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor
Led by Universität Münster · Updated on 2024-12-16
34
Participants Needed
1
Research Sites
216 weeks
Total Duration
On this page
Sponsors
U
Universität Münster
Lead Sponsor
P
photonamic GmbH & Co. KG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written patient consent after comprehensive information
- Age 18 years or older
- Recurrence of supratentorial glioblastoma after initial surgery and adjuvant therapy
- Second or third tumor recurrences allowed
- Planned further radiotherapy as part of recurrence treatment
- Histological confirmation of recurrent glioblastoma
- Karnofsky Performance Score of 60 or higher
- Willingness to use highly effective contraception during the study and for 6 months after first 5-ALA dose
- Negative pregnancy test within 72 hours before treatment start for pre-menopausal women with childbearing potential
- Adequate liver function with bilirubin less than 1.5 times upper limit of normal, or less than 3 times if Gilbert's disease is suspected
- Adequate kidney function with creatinine less than 3 times upper limit of normal and eGFR 60 ml/min or higher
- Blood clotting parameters within acceptable limits according to investigator
You will not qualify if you...
- Unable to undergo MRI, PET, or contrast-enhanced CT imaging
- Pregnant or breastfeeding women
- History of severe diseases with poor prognosis such as severe heart disease, heart failure (NYHA III/IV), uncontrolled diabetes, immune deficiency, severe neurological or systemic disorders
- Any active infection
- Hypersensitivity to porphyrins
- Known diagnosis of porphyria
- Participation in another clinical trial with therapeutic intervention since glioblastoma diagnosis
- Known intolerance to study medication
- Use of phototoxic or photosensitizing drugs within 2 weeks before radiodynamic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Münster, Klinik für Neurochirurgie
Münster, Germany, 48149
Actively Recruiting
Research Team
W
Walter Stummer, Prof. Dr.
CONTACT
H
Hans Theodor Eich, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here