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

Launched by PHOTONAMIC GMBH & CO. KG · Mar 28, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called stereotactic interstitial photodynamic therapy (iPDT) with a drug called PD L 506 for patients with a specific type of brain cancer known as glioblastoma. This trial focuses on newly diagnosed, unifocal (single), and lobar (located in one area of the brain) IDH wild-type glioblastomas that are not fully removable through surgery. The researchers want to find out if this treatment is safe and effective for patients aged 18 to 70 who have a good performance status and can expect to live at least three more months.

If you or a loved one qualify for this trial, you will receive the iPDT treatment and will be closely monitored for any side effects or benefits. Key eligibility criteria include having a biopsy-proven diagnosis of glioblastoma, not having any other serious health conditions that could interfere with the treatment, and being able to give informed consent. It’s important to know that women of childbearing potential will need to use effective contraception during the study. Overall, this trial aims to explore a promising new therapy for a challenging condition.

Gender

ALL

Eligibility 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 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 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.