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

NCT04469699 | Terminated Phase 2 DMC

• 2 other identifiers: UKM12_00172015-002727-25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (14)

• 6-month PFS rate

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

• Overall survival (OS)

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

• Progression free time

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

• 12-month OS rate

  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

  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

Study Arms (2)

Treatment arm

EXPERIMENTAL

Stereotactic biopsy followed by stereotactical photodynamic therapy

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

Control arm

OTHER

Stereotactic biopsy

Procedure: Stereotactic biopsy

Interventions

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

Also known as: Gliolan, 5-aminolevulinic acid

Treatment arm

Stereotactic biopsy PROCEDURE

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

Control arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator
• photonamic GmbH & Co. KG: collaborator
• medac GmbH: collaborator
• LifePhotonic GmbH: collaborator

Study Sites (4)

Medizinische Fakultät Carl Gustav Carus, Klinik und Poliklinik für Neurochirurgie

Dresden, 01307, Germany

Location

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

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Essen, Klinik für Neurochirurgie und Wirbelsäulenchirurgie

Essen, 45122, Germany

Location

Universitätsklinikum Münster, Klinik und Poliklinik für Neurochirurgie

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

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

  University Hospital Muenster, Klinik und Poliklinik für Neurochirurgie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: July 14, 2020
• Study Start: April 12, 2021
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)