Trial | NCT04469699  Report issue

Title

Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma
Controlled Clinical Trial to Evaluate the Safety and Efficacy of Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    106
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 Started
Apr 12
2021
Primary Completion
Apr 30
2026
Anticipated
Study Completion
Apr 30
2026
Anticipated
Last Update
Dec 21
2022

Drug Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid

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).

  • Other names: Gliolan, 5-aminolevulinic acid

Procedure Stereotactic biopsy

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

Treatment arm Experimental

Stereotactic biopsy followed by stereotactical photodynamic therapy

Control arm Other

Stereotactic biopsy

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted