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

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ClinicalTrials.gov Identifier: NCT03897491
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
photonamic GmbH & Co. KG

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: 5-aminolevulinic acid Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2025


Arm Intervention/treatment
Experimental: Interstitial photodynamic therapy
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
5-aminolevulinic acid powder for oral solution




Primary Outcome Measures :
  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. [ Time Frame: 2 weeks ]
    The incidence of treatment-emergent Adverse Events (TEAEs) of CTC grades III, IV and V (with the exception of expected Adverse Events) within two weeks following iPDT


Secondary Outcome Measures :
  1. Progression-free survival rate at 12 months [ Time Frame: 12 months ]
    Percentage of patients without tumor progression 12 months after iPDT

  2. Overall survival rate at 12 months [ Time Frame: 12 months ]
    Percentage of patients who are alive 12 months after iPDT

  3. Progression-free survival [ Time Frame: From date of iPDT until the date of first documented progression, up to 66 months ]
    Time until first tumor progression

  4. Overall survival [ Time Frame: From date of iPDT until the date of death from any cause, up to 66 months ]
    Time until death from any cause

  5. MGMT promoter methylation status of the patient [ Time Frame: Baseline ]
    Analytical results for MGMT promoter methylation status (methylated/unmethylated) in the respective tumor samples of each patient

  6. Immune status of the patient [ Time Frame: Baseline, 2 days, 2 weeks after iPDT and then every 3 months, up to 66 months ]
    Analytical results for immune parameters (PBMC, CD4+, CD8+) in the respective blood samples of each patient

  7. Results of investigator's assessment of patient's physical condition using Karnofsky performance status scale [ Time Frame: Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months ]
    To determine patient's physical condition using Karnofsky performance status scale ranging from 0% (worst outcome) to 100% (best outcome)

  8. Results of investigator's assessment of patient's mental condition using Mini-mental State Examination [ Time Frame: Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months ]
    To determine patient's mental condition using Mini-mental State Examination scale ranging from 0 (worst outcome) to 30 (best outcome)

  9. Results of investigator's assessment of patient's mental condition using National Institutes of Health Stroke Scale [ Time Frame: Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months ]
    To determine patient's mental condition using National Institutes of Health Stroke Scale ranging from 0 (best outcome) to 34 (worst outcome)

  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 (BM20) [ Time Frame: Baseline, 2 weeks after iPDT and then every 3 months, up to 66 months ]
    To determine patient's quality of life

  11. Interstitial light transmittance and fluorescence data recorded [ Time Frame: during iPDT treatment (up to 1 hour) ]
    To determine whether correlations exist between length of OS/PFS and spectral online-monitoring measurement results (transmission and fluorescence measurements)

  12. Interstitial fluorescence data recorded [ Time Frame: during iPDT treatment (up to 1 hour) ]
    To determine the rate of patients with fluorescence-negative tumors

  13. Percentage of cylindrical diffusor laser probes without kinks, cracks etc. before and after iPDT [ Time Frame: Day 0 (Treatment day), directly before and after iPDT ]
    Assessing the safety and performance of the insertion of Cylindrical Diffusor Laser Probes into the brain for iPDT of brain tumors.

  14. Percentage of iPDT treatments in which the laser system works properly as planned. [ Time Frame: Day 0 (Treatment day), directly after iPDT ]
    Assessing safety and performance of the laser system for iPDT of brain tumors.

  15. 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. [ Time Frame: Day 0 (Treatment day), directly after iPDT ]
    Assessing safety and performance of the combination of ML7710i laser system and Cylindrical Diffusor Laser Probes for the iPDT of brain tumors.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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 prior to or at Visit 1

Exclusion criteria:

  • 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
  • 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
  • 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.

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): NCT03897491


Contacts
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Contact: Marcus Stocker, Dr. +49(0)4103/8006-704 m.stocker@photonamic.de
Contact: Andrea Ebeling, Dr.

Locations
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Germany
Uniklinik Köln Not yet recruiting
Köln, Germany, 50924
Contact: Maximilian Ruge, Prof. Dr.         
Klinikum der Universität München Not yet recruiting
München, Germany, 81377
Contact: Niklas Thon, PD Dr.         
Universitätsklinikum Münster Not yet recruiting
Münster, Germany, 48149
Contact: Walter Stummer, Prof. Dr.         
Sponsors and Collaborators
photonamic GmbH & Co. KG
Investigators
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Principal Investigator: Niklas Thon, PD. Dr. med. Klinikum der Universität München

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Responsible Party: photonamic GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT03897491     History of Changes
Other Study ID Numbers: GL 01
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: March 2019
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