Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma (NOA11)

University Hospital Muenster

Status and phase: Terminated; Phase 2

Conditions: Glioblastoma Multiforme, Adult

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04469699

UKM12_0017

2015-002727-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Treatment arm

Experimental group

Description:

Stereotactic biopsy followed by stereotactical photodynamic therapy

Treatment:

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

Control arm

Other group

Description:

Stereotactic biopsy

Treatment:

Procedure: Stereotactic biopsy