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

• Status: Recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The trial is an open, multicenter, explorative, pilot phase II study in a small number of patients to assess safety and efficacy of stereotactic interstitial photodynamic therapy (iPDT) with PD L 506 in newly diagnosed supratentorial IDH wild-type glioblastoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: photonamic GmbH & Co. KG
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria:

• Biopsy proven, newly diagnosed, supratentorial, unifocal, lobar located IDH wild-type glioblastoma according to the criteria of the 2016 WHO classification.

• Not safely and/or not completely resectable, lobar located, unifocal, supratentorial IDH wild-type glioblastomas with a largest diameter ≤ 40 mm (largest diameter of the contrast enhanced tumor, as defined by enhanced T1 MRI sequences) are eligible in case of corresponding tumor board re-estimations.

• Potentially completely resectable, lobar located, unifocal, supratentorial, IDH wild-type glioblastoma with a largest diameter ≤ 40 mm are eligible in case of both patient's informed preference in favour of iPDT and corresponding tumor board recommendations.

• Age 18 - 70 years

• Karnofsky Performance status (KPS) of ≥ 70 %

• Minimal life expectancy of 3 months.

• Patients eligible for radiotherapy plus concomitant and adjuvant chemotherapy with temozolomide Adequate haematological function (Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count > 100 x 109/L, Haemoglobin > 10 g/dL (may be transfused to maintain or exceed this level)).

• International normalized ratio (INR) or PT (secs) and activated partial thromboplastin time (aPTT) ≤ 1,5 times of the upper limit of normal in the laboratory where it was measured.

• Negative pregnancy test in fertile women

• For female and male patients of reproductive potential: Willingness to apply highly effective contraception (Pearl index <1) during the entire study.

Such methods include :

• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:

• oral

• intravaginal

• transdermal

• progestogen-only hormonal contraception associated with inhibition of ovulation :

• oral

• injectable

• implantable

• intrauterine device (IUD)

• intrauterine hormone-releasing system (IUS)

• bilateral tubal occlusion

• vasectomised partner

• sexual abstinence • Written informed consent has been signed prior to or at Visit 1

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.