CTIS2023-510024-79-00Active, not recruitingPhase 1
Evaluation of the feasibility of PD L 506 for stereotactic interstitial photodynamic therapy (iPDT) in adult patients with newly diagnosed supratentorial IDH wild-type glioblastoma - GL 01
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Photonamic GmbH & Co. KG
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
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 wildtype 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 womenFor female and male patients of reproductive potential: Willingness to apply highly effective contraception (Pearl index <1) during the entire study. Such methods include3: - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal - progestogen-only hormonal contraception associated with inhibition of ovulation : o oral o injectable o implantable - intrauterine device (IUD) - intrauterine hormone-releasing system (IUS) - bilateral tubal occlusion - vasectomised partner - sexual abstinence ? Written informed consent has been signed and dated prior to or at the beginning of 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 ?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.
Investigators
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