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

NCT ID: NCT04469699

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2025-01-30

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 glioblastoma.

Conditions

Glioblastoma Multiforme, Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

Stereotactic biopsy followed by stereotactical photodynamic therapy

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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).

Control arm

Stereotactic biopsy

Group Type: OTHER

Stereotactic biopsy

Intervention Type: PROCEDURE

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

Interventions

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).

Intervention Type: DRUG

Stereotactic biopsy

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

Intervention Type: PROCEDURE

Other Intervention Names

Gliolan, 5-aminolevulinic acid

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

Sponsor Role: collaborator

photonamic GmbH & Co. KG

INDUSTRY

Sponsor Role: collaborator

medac GmbH

INDUSTRY

Sponsor Role: collaborator

LifePhotonic GmbH

UNKNOWN

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Stummer, Univ.-Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster, Klinik und Poliklinik für Neurochirurgie

Locations

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

Countries

Germany

Other Identifiers

2015-002727-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UKM12_0017

Identifier Type: -

Identifier Source: org_study_id