Niklas Thon, Prof. Dr. Principal Investigator Klinikum der Universität München
Kontakt
Marcus Stocker, Dr. Kontakt: Phone: +49(0)4101/7853-953 E-Mail: m.stocker@photonamic.de» Kontaktdaten anzeigen Friederike Haubenschild Kontakt: E-Mail: f.haubenschild@photonamic.de» Kontaktdaten anzeigen
Studienlocations (3 von 3)
Lungenkrebszentrum Uniklinik Köln / Solingen Kerpener Straße 62 50937 Köln DeutschlandNoch nicht rekrutierend» Google-Maps Ansprechpartner: Maximilian Ruge, Prof. Dr.» Ansprechpartner anzeigenBrustzentrum am Klinikum der Universität München Marchioninistraße 15 80337 München DeutschlandRekrutierend» Google-Maps Ansprechpartner: Niklas Thon, Prof. Dr.» Ansprechpartner anzeigenKinderonkologisches Zentrum am Universitätsklinikum Münster Albert-Schweitzer-Campus 1 48149 Münster DeutschlandRekrutierend» Google-Maps Ansprechpartner: Walter Stummer, Prof. Dr.» Ansprechpartner anzeigen
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.