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GlioblastomaPhase 2NCT03897491

PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma

A Phase 2 study testing 5-aminolevulinic acid in people with Glioblastoma, run by photonamic GmbH & Co. KG at 3 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The trial is an open, multicenter, explorative, pilot phase II study in a small number of patients to assess safety and efficacy of stereotactic interstitial photodynamic therapy (iPDT) with PD L 506 in newly diagnosed supratentorial IDH wild-type glioblastoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Glioblastoma
What is being tested?
5-aminolevulinic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesGermany
Study dates
3 Sep 2021to 8 Apr 2026
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy proven, newly diagnosed, supratentorial, unifocal, lobar located IDH wild-type glioblastoma according to the criteria of the 2016 WHO classification.
  • Not safely and/or not completely resectable, lobar located, unifocal, supratentorial IDH wild-type glioblastomas with a largest diameter ≤ 40 mm (largest diameter of the contrast enhanced tumor, as defined by enhanced T1 MRI sequences) are eligible in case of corresponding tumor board re-estimations.
  • Potentially completely resectable, lobar located, unifocal, supratentorial, IDH wild-type glioblastoma with a largest diameter ≤ 40 mm are eligible in case of both patient's informed preference in favour of iPDT and corresponding tumor board recommendations.
  • Age 18 - 70 years
  • Karnofsky Performance status (KPS) of ≥ 70 %
  • Minimal life expectancy of 3 months.
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  • Patients eligible for radiotherapy plus concomitant and adjuvant chemotherapy with temozolomide: Adequate haematological function (Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count > 100 x 109/L, Haemoglobin > 10 g/dL (may be transfused to maintain or exceed this level)).
  • International normalized ratio (INR) or PT (secs) and activated partial thromboplastin time (aPTT) ≤ 1,5 times of the upper limit of normal in the laboratory where it was measured.
  • Negative pregnancy test in fertile women
  • For female and male patients of reproductive potential: Willingness to apply highly effective contraception (Pearl index <1) during the entire study.
  • Such methods include :
  • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
  • oral
  • intravaginal
  • transdermal
  • progestogen-only hormonal contraception associated with inhibition of ovulation :
  • oral
  • injectable
  • implantable
  • intrauterine device (IUD)
  • intrauterine hormone-releasing system (IUS)
  • bilateral tubal occlusion
  • vasectomised partner
  • sexual abstinence • Written informed consent has been signed and dated prior to or at the beginning of Visit -1

Who cannot join

  • Glioblastomas involving the basal ganglia, the corpus callosum, the primary motor cortex, the ventricular system, multifocal tumors, and those involving the brain stem and/or the cerebellum.
  • Glioblastomas exceeding the 40 mm threshold in their largest diameter
  • Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
  • Hypersensitivity against porphyrins
  • Known diagnosis of porphyria
  • Acute or chronic hepatic diseases (levels of ASAT, ALAT and/or gamma-GT more than 2.5 times the upper limit of normal in the laboratory where it was measured)
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  • Manifest renal diseases with renal dysfunction (serum creatinine level > 1.5 times of the upper limit of normal in the laboratory where it was measured)
  • Severe, active co-morbidity:
  • Unstable angina and/or congestive heart failure within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • History of stroke, cerebral vascular accident, or transient ischemic attack within 6 months
  • Serious and inadequately controlled cardiac arrhythmia
  • Significant vascular disease (e.g. aortic aneurysm)
  • Evidence of bleeding diathesis or coagulopathy
  • Acute bacterial or fungal infections
  • Acute exacerbation of chronic obstructive pulmonary disease
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulopathy
  • Acquired immune deficiency syndrome; note, however, that HIV testing is not required for study entry.
  • Inability to undergo MRI (e.g., presence of a pacemaker)
  • Known intolerance to study medication
  • Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
  • Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment or within 5 plasma half-life of the preceding study drug, whatever is longer.
  • Pregnancy or breastfeeding
  • In case of both complete absence of intra-operative fluorescence between any of the inserted light diffusers and absence of significant surgery-associated bleedings (i.e. light transmission is detectable between at least two of the inserted light diffusers), the tumor will be classified as 'fluorescence-negative tumor'. iPDT will however be performed. Regarding efficacy evaluation, patients with fluorescence-negative tumors will be excluded from PP-, but included in the ITT-evaluation, and will be evaluated regarding safety.

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Uniklinik Köln

    Cologne, 50924

  • Klinikum der Universität München

    München, 81377

  • Universitätsklinikum Münster

    Münster, 48149

Other trials in Germany

About this study

Official title: Evaluation of the Feasibility of PD L 506 for Stereotactic Interstitial Photodynamic Therapy (iPDT) in Adult Patients With Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma

The trial is an open, multicenter, explorative, pilot phase II study in a small number of patients to assess safety and efficacy of stereotactic interstitial photodynamic therapy (iPDT) with PD L 506 in newly diagnosed supratentorial IDH wild-type glioblastoma.

Conditions
Glioblastoma
Being tested
5-aminolevulinic acid
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-aminolevulinic acidDrug

    5-aminolevulinic acid powder for oral solution

Study groups in NCT03897491
Study groupRoleWhat they receive
Interstitial photodynamic therapyExperimental20 mg 5-aminolevulinic acid per kg body weight orally four hours (range 3,5-4,5 hours) before the induction of general anaesthesia.
Receives: Drug: 5-aminolevulinic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the incidence of treatment-emergent Adverse Events (safety and tolerability) of iPDT with PD L 506 in adult patients with newly diagnosed supratentorial IDH wild-type glioblastoma.

    The incidence of treatment-emergent Adverse Events (TEAEs) of CTC grades 3, 4 and 5 within two weeks following iPDT

    Measured: 2 weeks

Secondary outcomes (16)

  1. Progression-free survival rate at 12 months

    Percentage of patients without tumor progression 12 months after iPDT

    Measured: 12 months

  2. Overall survival rate at 12 months

    Percentage of patients who are alive 12 months after iPDT

    Measured: 12 months

  3. Progression-free survival

    Time until first tumor progression

    Measured: From date of iPDT until the date of first documented progression, up to 66 months

  4. Overall survival

    Time until death from any cause

    Measured: From date of iPDT until the date of death from any cause, up to 66 months

  5. MGMT promoter methylation status of the patient

    Analytical results for MGMT promoter methylation status (methylated/unmethylated) in the respective tumor samples of each patient

    Measured: Baseline

  6. Immune status of the patient

    Analytical results for immune parameters (PBMC, CD4+, CD8+) in the respective blood samples of each patient

    Measured: Baseline, 2 days, 2 weeks after iPDT and then every 3 months, up to 66 months

  7. Results of investigator's assessment of patient's physical condition using Karnofsky performance status scale

    To determine patient's physical condition using Karnofsky performance status scale ranging from 0% (worst outcome) to 100% (best outcome)

    Measured: Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months

  8. Results of investigator's assessment of patient's mental condition using Mini-mental State Examination

    To determine patient's mental condition using Mini-mental State Examination scale ranging from 0 (worst outcome) to 30 (best outcome)

    Measured: Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months

  9. Results of investigator's assessment of patient's mental condition using National Institutes of Health Stroke Scale

    To determine patient's mental condition using National Institutes of Health Stroke Scale ranging from 0 (best outcome) to 34 (worst outcome)

    Measured: Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months

  10. Results of investigator's assessment of patient's condition using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients Questionnaire (QLQ-C30) together with the Brain module (BN20)

    To determine patient's quality of life

    Measured: Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months

  11. Interstitial light transmittance and fluorescence data recorded

    To determine whether correlations exist between length of OS/PFS and spectral online-monitoring measurement results (transmission and fluorescence measurements)

    Measured: during iPDT treatment (up to 1 hour)

  12. Interstitial fluorescence data recorded

    To determine the rate of patients with fluorescence-negative tumors

    Measured: during iPDT treatment (up to 1 hour)

  13. Percentage of cylindrical diffusor laser probes without kinks, cracks etc. before and after iPDT for patients treated under protocol versions prior to V7.0

    Assessing the safety and performance of the insertion of Cylindrical Diffusor Laser Probes into the brain for iPDT of brain tumors for patients treated under protocol versions prior to V7.0.

    Measured: Day 0 (Treatment day), directly before and after iPDT

  14. Percentage of guiding catheters without kinks, cracks etc. before and after iPDT

    Assessing the safety and performance of the insertion of guiding catheters into the brain for iPDT of brain tumors

    Measured: Day 0 (Treatment day), directly before and after iPDT

  15. Percentage of iPDT treatments in which the laser system works properly as planned.

    Assessing safety and performance of the laser system for iPDT of brain tumors.

    Measured: Day 0 (Treatment day), directly after iPDT

  16. Percentage of fibers/laser ports which show a maximum deviation in the output power of less than +/-10% to the pre-defined output power of 200 mW/cm diffusor length.

    Assessing safety and performance of the combination of ML7710i laser system and Cylindrical Diffusor Laser Probes for the iPDT of brain tumors.

    Measured: Day 0 (Treatment day), directly after iPDT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2019
  2. Study start3 Sep 2021
  3. Primary completion8 Apr 2026
  4. Study completion8 Apr 2026

Why it stopped: Low recruitment activities of clinical trial sites.

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03897491
Sponsor's protocol ID
GL 01
Other IDs
2023-510024-79-00, 2023
Status last verified
May 2026
First submitted
19 Mar 2019
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5-aminolevulinic acid in people with Glioblastoma, run by photonamic GmbH & Co. KG at 3 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 24 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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: Low recruitment activities of clinical trial sites.). 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?

To determine the incidence of treatment-emergent Adverse Events (safety and tolerability) of iPDT with PD L 506 in adult patients with newly diagnosed supratentorial IDH wild-type glioblastoma. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03897491.

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 1 Jun 2026.

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