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

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ClinicalTrials.gov Identifier: NCT04469699
Recruitment Status : Not yet recruiting
First Posted : July 14, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany)
photonamic GmbH & Co. KG
medac GmbH
LifePhotonic GmbH
Information provided by (Responsible Party):
University Hospital Muenster

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme, Adult Drug: Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid Procedure: Stereotactic biopsy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Controlled Clinical Trial to Evaluate the Safety and Efficacy of Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025


Arm Intervention/treatment
Experimental: Treatment arm
Stereotactic biopsy followed by stereotactical photodynamic therapy
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).
Other Name: Gliolan, 5-aminolevulinic acid

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




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: through study completion (at least 1.5 years and a maximum of 5 years) or until progression or death ]
    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


Secondary Outcome Measures :
  1. 6-month PFS rate [ Time Frame: for each patient up to 6 months after randomization or until progression has occurred ]
    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 or death from any cause

  2. Overall survival (OS) [ Time Frame: through study completion (at least 1.5 years and a maximum of 5 years) or until death ]
    Overall survival (OS) measured as time from the day of randomization until death

  3. Progression free time [ Time Frame: through study completion (at least 1.5 years and a maximum of 5 years) or until progression ]
    Progression free time as time from the day of randomization until progressive disease (death is regarded as censored)

  4. 12-month OS rate [ Time Frame: for each patient up to 12 months after randomization or until death ]
    Overall survival (OS) measured as time from the day of randomization until death

  5. 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 [ Time Frame: 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 ]
  6. 48h response rate on MRI (Complete Remission, Partial Remission, Stable Disease) after treatment with iPDT (interstitial photodynamic therapy) [ Time Frame: 26 - 48 hours after stereotactic procedure in patients treated with interstitial photodynamic therapy (iPDT) ]
    Response is assessed according to the RANO criteria

  7. If a PET (positron emission tomography) was performed less than 2 weeks apart from an MRI: Consistency of both procedures with regard to the region of interest (ROI) [ Time Frame: 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 ]
  8. Change in KPS (Karnofsky Performance Score) [ Time Frame: Baseline, 26 -48 hours after stereotactic procedure, upon discharge or 7 days after stereotactic procedure, 1 month after randomization and then every 2 months until 1.5 years after randomization or disease progression ]
    Minimum value: 0, maximum value: 100. A higher value means a better outcome.

  9. Change in NIHSS (National Institutes of Health Stroke Scale) [ Time Frame: Baseline, 26 -48 hours after stereotactic procedure, upon discharge or 7 days after stereotactic procedure, 1 month after randomization and then every 2 months until 1.5 years after randomization or disease progression ]
    Minimum value: 0, maximum value: 42. A higher value means a worse outcome.

  10. Change in MMSE (Mini-Mental State Examination) [ Time Frame: Baseline, 26 -48 hours after stereotactic procedure, upon discharge or 7 days after stereotactic procedure, 1 month after randomization and then every 2 months until 1.5 years after randomization or disease progression ]
    Minimum value: 0, maximum value: 30. A higher value means a better outcome.

  11. Brain edema as assessed by MRI within 26 to 48 h after stereotactic surgery [ Time Frame: 26 to 48 hours after stereotactic intervention ]
  12. Frequency of Adverse Events [ Time Frame: over the entire study period of each patient (at least 1.5 years and a maximum of 5 years) ]
  13. Change in the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire) score during study participation [ Time Frame: Baseline, at discharge or 7 days after intervention, 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 ]
  14. Change in the EORTC QLQ-BN20 module (European Organisation for Research and Treatment of Cancer Quality of Life Brain Cancer Module) score during study participation [ Time Frame: Baseline, at discharge or 7 days after intervention, 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469699


Contacts
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Contact: Juliane Schroeteler, Dr. med. +491733802878 juliane.schroeteler@ukmuenster.de

Locations
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Germany
Medizinische Fakultät Carl Gustav Carus, Klinik und Poliklinik für Neurochirurgie
Dresden, Germany, 01307
Universitätsklinikum Düsseldorf, Klinik für Neurochirurgie, Abteilung Funktionelle NC & Stereotaxie
Düsseldorf, Germany, 40225
Universitätsklinikum Essen, Klinik für Neurochirurgie und Wirbelsäulenchirurgie
Essen, Germany, 45122
LMU München, Campus Großhadern, Neurochirurgische Klinik und Poliklinik
München, Germany, 81377
Universitätsklinikum Münster, Klinik und Poliklinik für Neurochirurgie
Münster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Deutsche Krebshilfe e.V., Bonn (Germany)
photonamic GmbH & Co. KG
medac GmbH
LifePhotonic GmbH
Investigators
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Principal Investigator: Walter Stummer, Univ.-Prof. Dr. med. University Hospital Muenster, Klinik und Poliklinik für Neurochirurgie
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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT04469699    
Other Study ID Numbers: UKM12_0017
2015-002727-25 ( EudraCT Number )
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents