Status:
TERMINATED
Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Deutsche Krebshilfe e.V., Bonn (Germany)
photonamic GmbH & Co. KG
Conditions:
Glioblastoma Multiforme, Adult
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
In this multicenter, randomized, non-blinded trial the efficacy and safety of stereotactical photodynamic therapy with 5-aminolevulinic acid will be investigated in 106 patients with recurrent gliobla...
Eligibility Criteria
Inclusion
- Written informed consent
- Age 18 - 75 years
- Karnofsky Performance Score (KPS) of ≥60 %
- Radiologically suspected diagnosis (according to RANO criteria) of the first recurrence of a glioblastoma located in the cerebral hemisphere including insular 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. Not necessarily identical to primary tumor location
- Single or single progressive contrast-enhancing lesion on MRI, largest diameter not more than 2.5 cm
- For female and male patients of reproductive potential: Willingness to apply highly effective contraception (Pearl index \<1) during the entire study
Exclusion
- Multifocal disease \> 2 locations
- Patients with significant non-enhancing tumor portions
- Previous treatment of recurrence
- Other malignant disease except basalioma
- Hypersensitivity against porphyrins or Gliolan® or Fluorethylenpropylen (FEP )
- Porphyria
- HIV infection, active Hepatitis B or C infection
- Bone marrow reserve:
- white blood cell (WBC) count \<2000/μl,
- platelets \<100000/μl,
- Liver function:
- total bilirubin \> 1.5 times above upper limit of normal range (ULN)
- alanine transaminase (ALT) and aspartate transaminase (AST) \> 3 times ULN
- Renal function:
- \- creatinine \> 1.5 times ULN
- Blood clotting:
- \- Quick/INR or PTT out of acceptable limits
- Conditions precluding MRI (e.g. pacemaker)
- 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)
- Any active infection (at the discretion of the investigator)
- 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
- Previous antiangiogenic treatment
- Participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial.
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04469699
Start Date
April 12 2021
End Date
January 30 2025
Last Update
March 11 2025
Active Locations (4)
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1
Medizinische Fakultät Carl Gustav Carus, Klinik und Poliklinik für Neurochirurgie
Dresden, Germany, 01307
2
Universitätsklinikum Düsseldorf, Klinik für Neurochirurgie, Abteilung Funktionelle NC & Stereotaxie
Düsseldorf, Germany, 40225
3
Universitätsklinikum Essen, Klinik für Neurochirurgie und Wirbelsäulenchirurgie
Essen, Germany, 45122
4
Universitätsklinikum Münster, Klinik und Poliklinik für Neurochirurgie
Münster, Germany, 48149