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

NCT03897491 | Terminated Phase 2

• 2 other identifiers: GL 012023-510024-79-00
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (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

  2 weeks

Secondary Outcomes (16)

• Progression-free survival rate at 12 months

  12 months

• Overall survival rate at 12 months

  12 months

• Progression-free survival

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

• Overall survival

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

• MGMT promoter methylation status of the patient

  Baseline

Study Arms (1)

Interstitial photodynamic therapy

EXPERIMENTAL

20 mg 5-aminolevulinic acid per kg body weight orally four hours (range 3,5-4,5 hours) before the induction of general anaesthesia.

Drug: 5-aminolevulinic acid

Interventions

5-aminolevulinic acid DRUG

5-aminolevulinic acid powder for oral solution

Interstitial photodynamic therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• photonamic GmbH & Co. KG: lead

Study Sites (3)

Uniklinik Köln

Cologne, 50924, Germany

Location

Klinikum der Universität München

München, 81377, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Walter Stummer, Prof. Dr.

  Universitätsklinikum Münster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: April 1, 2019
• Study Start: September 3, 2021
• Primary Completion: April 8, 2026
• Study Completion: April 8, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)