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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
5-aminolevulinic acid powder for oral solution
Uniklinik Köln
Cologne, Germany
Klinikum der Universität München
München, Germany
Universitätsklinikum Münster
Münster, Germany
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.
The incidence of treatment-emergent Adverse Events (TEAEs) of CTC grades 3, 4 and 5 within two weeks following iPDT
Time frame: 2 weeks
Progression-free survival rate at 12 months
Percentage of patients without tumor progression 12 months after iPDT
Time frame: 12 months
Overall survival rate at 12 months
Percentage of patients who are alive 12 months after iPDT
Time frame: 12 months
Progression-free survival
Time until first tumor progression
Time frame: From date of iPDT until the date of first documented progression, up to 66 months
Overall survival
Time until death from any cause
Time frame: From date of iPDT until the date of death from any cause, up to 66 months
MGMT promoter methylation status of the patient
Analytical results for MGMT promoter methylation status (methylated/unmethylated) in the respective tumor samples of each patient
Time frame: Baseline
Immune status of the patient
Analytical results for immune parameters (PBMC, CD4+, CD8+) in the respective blood samples of each patient
Time frame: Baseline, 2 days, 2 weeks after iPDT and then every 3 months, up to 66 months
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Results of investigator's assessment of patient's physical condition using Karnofsky performance status scale
To determine patient's physical condition using Karnofsky performance status scale ranging from 0% (worst outcome) to 100% (best outcome)
Time frame: Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months
Results of investigator's assessment of patient's mental condition using Mini-mental State Examination
To determine patient's mental condition using Mini-mental State Examination scale ranging from 0 (worst outcome) to 30 (best outcome)
Time frame: Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months
Results of investigator's assessment of patient's mental condition using National Institutes of Health Stroke Scale
To determine patient's mental condition using National Institutes of Health Stroke Scale ranging from 0 (best outcome) to 34 (worst outcome)
Time frame: Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months
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)
To determine patient's quality of life
Time frame: Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months
Interstitial light transmittance and fluorescence data recorded
To determine whether correlations exist between length of OS/PFS and spectral online-monitoring measurement results (transmission and fluorescence measurements)
Time frame: during iPDT treatment (up to 1 hour)
Interstitial fluorescence data recorded
To determine the rate of patients with fluorescence-negative tumors
Time frame: during iPDT treatment (up to 1 hour)
Percentage of cylindrical diffusor laser probes without kinks, cracks etc. before and after iPDT for patients treated under protocol versions prior to V7.0
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.
Time frame: Day 0 (Treatment day), directly before and after iPDT
Percentage of guiding catheters without kinks, cracks etc. before and after iPDT
Assessing the safety and performance of the insertion of guiding catheters into the brain for iPDT of brain tumors
Time frame: Day 0 (Treatment day), directly before and after iPDT
Percentage of iPDT treatments in which the laser system works properly as planned.
Assessing safety and performance of the laser system for iPDT of brain tumors.
Time frame: Day 0 (Treatment day), directly after iPDT
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.
Assessing safety and performance of the combination of ML7710i laser system and Cylindrical Diffusor Laser Probes for the iPDT of brain tumors.
Time frame: Day 0 (Treatment day), directly after iPDT