Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma

Phase 2TerminatedNCT04469699

University Hospital Muenster30 enrolled

Overview

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 glioblastoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma Multiforme, Adult

Interventions

Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acidDRUG

5-ALA HCl orally (20 mg/kg bw) 3,5-4,5 hours prior to induction of anaesthesia for stereotactic biopsy followed by stereotactical photodynamic therapy. All patients will receive further treatment of recurrent glioblastoma at the investigator´s discretion (best possible care).

Stereotactic biopsyPROCEDURE

Stereotactic biopsy. All patients will receive further treatment of recurrent glioblastoma at the investigator´s discretion (best possible care).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 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 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 \<1) during the entire study Exclusion Criteria: 1. Multifocal disease \> 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 Fluorethylenpropylen (FEP ) 6. Porphyria 7. HIV infection, active Hepatitis B or C infection 8. Bone marrow reserve: * white blood cell (WBC) count \<2000/μl, * platelets \<100000/μl, 9. Liver function: * total bilirubin \> 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 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

Locations (4)

Medizinische Fakultät Carl Gustav Carus, Klinik und Poliklinik für Neurochirurgie

Dresden, Germany

Universitätsklinikum Düsseldorf, Klinik für Neurochirurgie, Abteilung Funktionelle NC & Stereotaxie

Düsseldorf, Germany

Universitätsklinikum Essen, Klinik für Neurochirurgie und Wirbelsäulenchirurgie

Essen, Germany

Universitätsklinikum Münster, Klinik und Poliklinik für Neurochirurgie

Münster, Germany

Outcomes

Primary Outcomes

Progression free survival (PFS)

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 (Response Assessment in Neuro-Oncology Criteria) or death from any cause

Time frame: through study completion (at least 1.5 years and a maximum of 5 years) or until progression or death

Secondary Outcomes

6-month PFS rate

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

Time frame: for each patient up to 6 months after randomization or until progression has occurred

Overall survival (OS)

Overall survival (OS) measured as time from the day of randomization until death

Time frame: through study completion (at least 1.5 years and a maximum of 5 years) or until death

Progression free time

Progression free time as time from the day of randomization until progressive disease (death is regarded as censored)

Time frame: through study completion (at least 1.5 years and a maximum of 5 years) or until progression

12-month OS rate

Overall survival (OS) measured as time from the day of randomization until death

Time frame: for each patient up to 12 months after randomization or until death

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

Time frame: Baseline, 26 - 48 hours after stereotactic procedure, 1 month after randomization and then every 2 months, 1.5 years after randomization or at disease progression, and then every 3 months until end of entire study (up to 5 years) or progression

Data from ClinicalTrials.gov

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