Recurrent glioblastoma MedDRA version: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Gliolan 30 mg/ml powder for oral solution
Pharmaceutical Form: Powder for oral solution
CAS Number: 5451-09-2
Other descriptive name: AMINOLEVULINIC ACID HYDROCHLORIDE
Concentration unit:
Sponsors
Universitätsklinikum Münster
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Age 18 - 75 years 3. Karnofsky Performance Score (KPS) of =60 % 4. Radiologically suspected diagnosis (according to RANO criteria) of the first recurrence of a glioblastoma located in the cerebral hemisphere including insular lobe and diencephalon. Tumors in the brain stem are excluded. First MRI with signs of first recurrence (radiologic RANO criteria for disease progression) within 8 weeks prior to Informed Consent. Recurrent tumor must not necessarily be in the same location as primary tumor. 5. Single or single progressive contrast-enhancing lesion on MRI, largest diameter not more than 2.5 cm 6. For female and male patients of reproductive potential: Willingness to apply highly effective contraception (Pearl index =65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: 1. Multifocal disease in more than 2 locations 2. Patients with significant non enhancing tumor portions 3. Previous treatment of recurrence 4. Other malignant disease except basalioma 5. Hypersensitivity against porphyrins or Gliolan® or FEP (Fluorethylenpropylen) 6. Porphyria 7. HIV infection, active Hepatitis B or C infection 8. Bone marrow reserve: white blood cell (WBC) count 1.5 times above upper limit of normal range (ULN) alanine transaminase (ALT) and aspartate transaminase (AST) > 3 times ULN 10. Renal function: creatinine > 1.5 times ULN 11. Blood clotting: Quick/INR, PT or PTT out of acceptable limits 12. Conditions precluding MRI (e.g. pacemaker) 13. Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, heart failure (NYHA III/IV), severe poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) 14. Any active infection (at the discretion of the investigator) 15. Any psychological, cognitive, familial, sociological or geographical condition that, in the investigator’s opinion, compromises the patient’s ability to understand the patient information, to give informed consent or to comply with the trial protocol 16. Previous antiangiogenic treatment 17. Participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial. 18. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study is initiated to compare the following treatment concepts of recurrent glioblastoma with respect to efficacy, safety and quality of life: • iPDT (interstitial photodynamic therapy) with 5-ALA and consecutive therapy at the investigator’s discretion • Therapy at the investigator’s discretion without iPDT. ;Secondary Objective: Not applicable;Primary end point(s): Progression free survival (PFS) measured as time from the day of randomization until diagnosis of progressive disease as determined by MRI according to RANO criteria or death from any cause;Timepoint(s) of evaluation of this end point: At Visit 1 (1 month after randomization) and every second month after Visit 1 in the first 1.5 years of study participation and then every 3 months until disease progression or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 6-month PFS rate • Overall survival (OS) measured as time from the day of randomization until death • Progression free time as time from the day of randomization until progressive disease (death is regarded as censored) • 12-month OS rate • Absolute changes from baseline in contrast medium volume uptake from the MRI performed 48 hours after randomization on, and during any MRI performed thereafter to monitor for disease progression • 48h response rate on MRI (CR, PR, SD) after treatment with iPDT • If a PET was performed less than 2 weeks apart from an MRI: Consistency of both procedures with regard to the region of interest • Change in KPS, NIHSS, MMSE • Brain edema as assessed by MRI within 26 to 48 h after stereotactic surgery • Change from baseline in the EORTC QLQ-C30 score and the score assessed by means of the QLQ-BN20 module during study participation;Timepoint(s) of evaluation of this end point: At Visit 1 (1 month after randomization) and every second month after Visit 1 in the first 1.5 years of study participation and then every 3 months until disease progression or death | — |
Countries
Germany
Contacts
Public ContactKlinik für Neurochirurgie
Universitätsklinikum Münster
Outcome results
None listed