PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma

Exclusion Criteria

• •Glioblastomas involving the basal ganglia, the corpus callosum, the primary motor cortex, the ventricular system, multifocal tumors, and those involving the brain stem and/or the cerebellum.
• •Glioblastomas exceeding the 40 mm threshold in their largest diameter
• •Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
• •Hypersensitivity against porphyrins
• •Known diagnosis of porphyria
• •Acute or chronic hepatic diseases (levels of ASAT, ALAT and/or gamma-GT more than 2.5 times the upper limit of normal in the laboratory where it was measured)
• •Manifest renal diseases with renal dysfunction (serum creatinine level \> 1.5 times of the upper limit of normal in the laboratory where it was measured)
• •Severe, active co-morbidity:
• •Unstable angina and/or congestive heart failure within the last 6 months
• •Transmural myocardial infarction within the last 6 months
• •History of stroke, cerebral vascular accident, or transient ischemic attack within 6 months
• •Serious and inadequately controlled cardiac arrhythmia
• •Significant vascular disease (e.g. aortic aneurysm)
• •Evidence of bleeding diathesis or coagulopathy
• •Acute bacterial or fungal infections
• •Acute exacerbation of chronic obstructive pulmonary disease
• •Hepatic insufficiency resulting in clinical jaundice and/or coagulopathy
• •Acquired immune deficiency syndrome; note, however, that HIV testing is not required for study entry.
• •Inability to undergo MRI (e.g., presence of a pacemaker)
• •Known intolerance to study medication
• •Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
• •Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment or within 5 plasma half-life of the preceding study drug, whatever is longer.
• •Pregnancy or breastfeeding
• •In case of both complete absence of intra-operative fluorescence between any of the inserted light diffusers and absence of significant surgery-associated bleedings (i.e. light transmission is detectable between at least two of the inserted light diffusers), the tumor will be classified as 'fluorescence-negative tumor'. iPDT will however be performed. Regarding efficacy evaluation, patients with fluorescence-negative tumors will be excluded from PP-, but included in the ITT-evaluation, and will be evaluated regarding safety.