Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor
ConditionGlioblastoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversität Münster
About this trial
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.
Eligibility criteria
Qualifiers
Written patient consent after comprehensive information
Age >/= 18 years
Recurrence of supratentorial glioblastoma after initial resection and adjuvant therapy (e.g. radio-chemotherapy, targeted therapies, antiangiogenic therapies as determined by the tumor board) (with planned second resection cohort 0 and 1), second or third recurrences permitted
Clinically indicated further radiotherapy as per decision of the tumor board as part of therapy for recurrence
Disqualifiers
Patient unable to undergo imaging by MRI, PET or contrast-enhanced CT for whatever reason (e.g. pace-maker)
Pregnant and breastfeeding women
Past medical history of diseases with poor prognosis, e.g., severe coronary heart disease, heart failure (NYHA III/IV), severe and poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
Any active infection (at the discretion of the investigator)
Trial design
Treatments tested in this trial
- Gliolan
- Radiodynamic therapy
Treatment groups
34 Participants
are divided into 1 treatment groupSponsors and collaborators
Universität Münster
Lead sponsor
photonamic GmbH & Co. KG
Collaborator
Source ClinicalTrials.gov