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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04469699
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital Muenster
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Walter Stummer, Univ.-Prof. Dr. med.
Principal Investigator Affiliation	University Hospital Muenster, Klinik und Poliklinik für Neurochirurgie
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme, Adult

Arms & Interventions

Arms

Experimental: Treatment arm

Stereotactic biopsy followed by stereotactical photodynamic therapy

Other: Control arm

Stereotactic biopsy

Interventions

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).

Procedure: - Stereotactic biopsy

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.