Glioblastoma Multiforme, AdultPhase 2NOA11NCT04469699
Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma
A Phase 2 study testing Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid and Stereotactic biopsy in people with Glioblastoma Multiforme, Adult, run by University Hospital Muenster at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma Multiforme, Adult
- What is being tested?
- Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid and Stereotactic biopsy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesGermany
- Study dates
- 12 Apr 2021to 30 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
- Blood clotting:
- Quick/INR or PTT out of acceptable limits
- Conditions precluding MRI (e.g. pacemaker)
- 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)
- Any active infection (at the discretion of the investigator)
- 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
- Previous antiangiogenic treatment
- Participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial.
- Pregnancy or breastfeeding
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Medizinische Fakultät Carl Gustav Carus, Klinik und Poliklinik für Neurochirurgie
Dresden, 01307
Universitätsklinikum Düsseldorf, Klinik für Neurochirurgie, Abteilung Funktionelle NC & Stereotaxie
Düsseldorf, 40225
Universitätsklinikum Essen, Klinik für Neurochirurgie und Wirbelsäulenchirurgie
Essen, 45122
Universitätsklinikum Münster, Klinik und Poliklinik für Neurochirurgie
Münster, 48149
About this study
Official title: Controlled Clinical Trial to Evaluate the Safety and Efficacy of Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma
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
- Being tested
- Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid, Stereotactic biopsy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acidDrug
Also called Gliolan, 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).
Stereotactic biopsyProcedure or surgery
Stereotactic biopsy. All patients will receive further treatment of recurrent glioblastoma at the investigator´s discretion (best possible care).
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Stereotactic biopsy followed by stereotactical photodynamic therapy Receives: Drug: Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid |
| Control arm | Other | Stereotactic biopsy Receives: Procedure: Stereotactic biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: for each patient up to 6 months after randomization or until progression has occurred
Overall survival (OS)
Overall survival (OS) measured as time from the day of randomization until death
Measured: through study completion (at least 1.5 years and a maximum of 5 years) or until death
Progression free time
Progression free time as time from the day of randomization until progressive disease (death is regarded as censored)
Measured: through study completion (at least 1.5 years and a maximum of 5 years) or until progression
12-month OS rate
Overall survival (OS) measured as time from the day of randomization until death
Measured: 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
Measured: 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
48h response rate on MRI (Complete Remission, Partial Remission, Stable Disease) after treatment with iPDT (interstitial photodynamic therapy)
Response is assessed according to the RANO criteria
Measured: 26 - 48 hours after stereotactic procedure in patients treated with interstitial photodynamic therapy (iPDT)
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)
Measured: 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
Change in KPS (Karnofsky Performance Score)
Minimum value: 0, maximum value: 100. A higher value means a better outcome.
Measured: 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
Change in NIHSS (National Institutes of Health Stroke Scale)
Minimum value: 0, maximum value: 42. A higher value means a worse outcome.
Measured: 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
Change in MMSE (Mini-Mental State Examination)
Minimum value: 0, maximum value: 30. A higher value means a better outcome.
Measured: 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
Brain edema as assessed by MRI within 26 to 48 h after stereotactic surgery
Measured: 26 to 48 hours after stereotactic intervention
Frequency of Adverse Events
Measured: over the entire study period of each patient (at least 1.5 years and a maximum of 5 years)
Change in the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire) score during study participation
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start12 Apr 2021
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany), photonamic GmbH & Co. KG, medac GmbH, LifePhotonic GmbH
- Responsible party
- Sponsor
- Investigators
- Walter Stummer, Univ.-Prof. Dr. med., Principal investigator, University Hospital Muenster, Klinik und Poliklinik für Neurochirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469699
- Sponsor's protocol ID
- UKM12_0017
- Other IDs
- 2015-002727-25, 2015
- Acronym
- NOA11
- Status last verified
- Mar 2025
- First submitted
- 12 May 2020
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Clinical Trial to Evaluate the Safety and Efficacy of Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT04469699
- Acronym / sponsor ID
- NOA11 / UKM12_0017
- Conditions
- Glioblastoma Multiforme, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany), photonamic GmbH & Co. KG, medac GmbH, LifePhotonic GmbH
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acidStereotactic biopsy followed by stereotactical photodynamic therapy |
| Control arm | Other | Procedure: Stereotactic biopsyStereotactic biopsy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acidAlso: Gliolan, 5-aminolevulinic acid5-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). | Drug | Treatment arm |
| Stereotactic biopsyStereotactic biopsy. All patients will receive further treatment of recurrent glioblastoma at the investigator´s discretion (best possible care). | Procedure or surgery | Control arm |
Primary outcome
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
14 secondary outcomes
6-month PFS rate
Time frame: for each patient up to 6 months after randomization or until progression has occurred
Overall survival (OS)
Time frame: through study completion (at least 1.5 years and a maximum of 5 years) or until death
Progression free time
Time frame: through study completion (at least 1.5 years and a maximum of 5 years) or until progression
12-month OS rate
Time frame: 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
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
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)
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
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
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
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
Brain edema as assessed by MRI within 26 to 48 h after stereotactic surgery
Time frame: 26 to 48 hours after stereotactic intervention
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)
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
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
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Stummer, Univ.-Prof. Dr. med. principal investigator
University Hospital Muenster, Klinik und Poliklinik für Neurochirurgie
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid and Stereotactic biopsy in people with Glioblastoma Multiforme, Adult, run by University Hospital Muenster at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.