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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03897491

Studienbeginn:
September 2021

Letztes Update:
18.11.2023

Wirkstoff:
5-aminolevulinic acid

Indikation (Clinical Trials):
Glioblastoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
photonamic GmbH & Co. KG

Collaborator:
-

Studienleiter

Niklas Thon, Prof. Dr.
Principal Investigator
Klinikum der Universität München

Kontakt

Studienlocations
(3 von 3)

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. To determine the incidence of treatment-emergent Adverse Events (safety and tolerability) of iPDT with PD L 506 in adult patients with newly diagnosed supratentorial IDH wild-type glioblastoma. (Time Frame - 2 weeks):
The incidence of treatment-emergent Adverse Events (TEAEs) of CTC grades 3, 4 and 5 within two weeks following iPDT



Secondary outcome:

1. Progression-free survival rate at 12 months (Time Frame - 12 months):
Percentage of patients without tumor progression 12 months after iPDT

2. Overall survival rate at 12 months (Time Frame - 12 months):
Percentage of patients who are alive 12 months after iPDT

3. Progression-free survival (Time Frame - From date of iPDT until the date of first documented progression, up to 66 months):
Time until first tumor progression

4. Overall survival (Time Frame - From date of iPDT until the date of death from any cause, up to 66 months):
Time until death from any cause

5. MGMT promoter methylation status of the patient (Time Frame - Baseline):
Analytical results for MGMT promoter methylation status (methylated/unmethylated) in the respective tumor samples of each patient

6. Immune status of the patient (Time Frame - Baseline, 2 days, 2 weeks after iPDT and then every 3 months, up to 66 months):
Analytical results for immune parameters (PBMC, CD4+, CD8+) in the respective blood samples of each patient

7. Results of investigator's assessment of patient's physical condition using Karnofsky performance status scale (Time Frame - Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months):
To determine patient's physical condition using Karnofsky performance status scale ranging from 0% (worst outcome) to 100% (best outcome)

8. Results of investigator's assessment of patient's mental condition using Mini-mental State Examination (Time Frame - Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months):
To determine patient's mental condition using Mini-mental State Examination scale ranging from 0 (worst outcome) to 30 (best outcome)

9. Results of investigator's assessment of patient's mental condition using National Institutes of Health Stroke Scale (Time Frame - Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months):
To determine patient's mental condition using National Institutes of Health Stroke Scale ranging from 0 (best outcome) to 34 (worst outcome)

10. Results of investigator's assessment of patient's condition using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients Questionnaire (QLQ-C30) together with the Brain module (BN20) (Time Frame - Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months):
To determine patient's quality of life

11. Interstitial light transmittance and fluorescence data recorded (Time Frame - during iPDT treatment (up to 1 hour)):
To determine whether correlations exist between length of OS/PFS and spectral online-monitoring measurement results (transmission and fluorescence measurements)

12. Interstitial fluorescence data recorded (Time Frame - during iPDT treatment (up to 1 hour)):
To determine the rate of patients with fluorescence-negative tumors

13. Percentage of cylindrical diffusor laser probes without kinks, cracks etc. before and after iPDT for patients treated under protocol versions prior to V7.0 (Time Frame - Day 0 (Treatment day), directly before and after iPDT):
Assessing the safety and performance of the insertion of Cylindrical Diffusor Laser Probes into the brain for iPDT of brain tumors for patients treated under protocol versions prior to V7.0.

14. Percentage of guiding catheters without kinks, cracks etc. before and after iPDT (Time Frame - Day 0 (Treatment day), directly before and after iPDT):
Assessing the safety and performance of the insertion of guiding catheters into the brain for iPDT of brain tumors

15. Percentage of iPDT treatments in which the laser system works properly as planned. (Time Frame - Day 0 (Treatment day), directly after iPDT):
Assessing safety and performance of the laser system for iPDT of brain tumors.

16. Percentage of fibers/laser ports which show a maximum deviation in the output power of less than +/-10% to the pre-defined output power of 200 mW/cm diffusor length. (Time Frame - Day 0 (Treatment day), directly after iPDT):
Assessing safety and performance of the combination of ML7710i laser system and Cylindrical Diffusor Laser Probes for the iPDT of brain tumors.

Geprüfte Regime

  • 5-aminolevulinic acid:
    5-aminolevulinic acid powder for oral solution

Quelle: ClinicalTrials.gov


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