Evaluation of the efficacy and safety of stereotactical photodynamic therapy with 5-aminolevulinic acid (Gliolan®) in recurrent glioblastoma

Phase 1

• Conditions: Recurrent glioblastoma; MedDRA version: 20.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002727-25-DE
• Lead Sponsor: niversitätsklinikum Münster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-16
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 106

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 lobe 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. Recurrent tumor must not necessarily be in the same location as primary tumor.
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1. Multifocal disease in more than 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 FEP (Fluorethylenpropylen)
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, PT 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified