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Active, not recruitingNCT03395587GlioVaxUpdated Dec 2, 2024

Efficiency of Vaccination with Lysate-loaded Dendritic Cells in Patients with Newly Diagnosed Glioblastoma

A Phase 2 interventional study of Autologous, tumor lysate-loaded, mature dendritic cells (DC) and standard therapy in Glioblastoma, sponsored by Heinrich-Heine University, Duesseldorf. Active, not recruiting at 6 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by Heinrich-Heine University, Duesseldorf · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of the study is to determine whether overall survival of newly diagnosed glioblastoma patients treated with lysate-loaded, mature dendritic cell vaccines as add-on to the standard of care consisting of resection, radiotherapy with concomitant temozolomide chemotherapy and subsequent adjuvant temozolomide chemotherapy is superior to the treatment with the standard of care alone.

Read the detailed description

This is a multicenter, randomized, phase 2 study, integrating vaccination with tumorlysate-loaded mature dendritic cells into standard radio/temozolomide-chemotherapy of newly diagnosed glioblastoma patients with near-complete resection after fluorescence-guided resection. Only patients with confirmed gross-total resection and a residual tumor volume below 5 ml will be eligible for the trial. Vaccination will be performed after radio- and concomitant temozolomide chemotherapy and during the first three cycles of adjuvant TMZ.

02

Conditions studied

  • Glioblastoma

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Keywords

  • glioblastoma,
  • immunotherapy
  • dendritic cells
  • vaccination
03

In context

Glioblastoma

1,951 studies on the registry are indexed under Glioblastoma; 457 are open to participants now.

This study's enrollment of 136 is above the median of 36 across 1,645 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 180 studies on the registry; 54 are open to participants now.

Browse Heinrich-Heine University, Duesseldorf studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Determined at pre-screening (prior to surgery; wk-3 - wk-1):

  • Patients ≥ 18 years of age at surgery.
  • Patients must be in a cognitive state to understand and sign the informed consent indicating that they are aware of the investigational nature and procedures of the study.
  • First written informed consent for screening for eligibility, including tumor tissue collection, transfer and processing, central neuropathological evaluation of Tumor sample, central neuroradiological assessment of extent of resection, infectious disease (HIV, HBV, HCV, Treponema pallidum) testing, determination of MGMT promoter methylation status and pregnancy testing.

Determined at screening (at and post-surgery; d0 - wk3):

  • Newly diagnosed, monofocal GBM, IDH wildtype (WHO grade IV), including the histological variants of gliosarcoma and giant cell glioblastoma, confirmed by central neuropathologist according to the WHO classification of central nervous System tumors 2016. Tumors may cross into, but not beyond the corpus callosum.
  • Near-complete resection (≤ 5 ml residual contrast enhancing tumor volume) confirmed by central neuroradiologist on MRI scan within 72 h postoperative; awake surgery and second look surgery are possible, if medically indicated.
  • Sterile tumor sample of ≥ 150 mg with tumor cell frequency ≥ 60% as determined by central neuropathologist available for vaccine production.
  • Successful production of sterile, avital tumor lysate.
  • Karnofsky performance status ≥ 70%.
  • Adequate hepatic (serum glutamate pyruvate transferase/alanine transaminase (SGPT/ALT), serum glutamic oxaloacetate transaminase/aspartate transaminase (SGOT/AST) and alkaline phosphatase ≤ 3-times upper limit of normal (ULN); bilirubin ≤ 1.5-times ULN) and renal functions (creatinine ≤ 1.5-times ULN).
  • Adequate bone marrow function (hemoglobin ≥ 10 g/dl, thrombocytes ≥ 100,000/μl, white blood cell count ≥ 3,000/μl; neutrophil count ≥ 1,500/μl).
  • Prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x ULN unless therapeutically warranted. International normalized ratio (INR) (in absence of anticoagulation treatment) ≤ 1.5.
  • Systemic corticosteroids tapered down to ≤ 2 mg of dexamethasone or equivalent per day within 7 days postoperative (use of corticosteroids during the treatment period should be avoided, however it is possible if clinically indicated, but may require interruption of dendritic cell vaccination).
  • Female patients with reproductive potential and male generative patients and their female partners must agree to be true abstinent or to use a highly effective form of contraception (pearl index \< 1%) during the trial.
  • Patients must be in a cognitive state to understand and sign the informed consent indicating that they are aware of the investigational nature and procedures of the study.
  • Written informed consent to participate in study.

Exclusion criteria

Exclusion Criteria:

determined at pre-screening (prior to surgery; wk-3 - wk-1):

  • Medical history of severe acute or chronic disease with poor prognosis, e.g. severe coronary heart disease, heart failure (New York Heart Association classes III/IV), severe poorly controlled diabetes, severe mental retardation or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
  • Medical history of severe autoimmune disorder or immunodeficiency or patients with organ allograft.
  • Medical history of bleeding diathesis or coagulopathy.
  • Prior malignancy during the last three years except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer or cured, early-stage prostate cancer in a patient with prostate-specific antigen (PSA) level less than ULN.
  • Previous radiotherapy to head and neck.
  • Known allergy or intolerability to TMZ, dacarbazine, the contrast agent or to components of the dendritic cell vaccine.
  • Current treatment of glioblastoma in another clinical trial with therapeutic intervention or current use of any other investigational agent.
  • Known pregnancy or breast feeding.
  • No known severe infection requiring treatment.
  • Accommodation in an institution due to legal orders (§40(4) AMG).
  • Evidence of current drug or alcohol abuse. determined at screening (at and post-surgery; d0 - wk3):
  • Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or Treponema pallidum or other severe infection requiring treatment.
  • Accommodation in an institution due to legal orders (§40(4) AMG).
  • Pregnant or breast feeding female patients. From pre-menopausal female patients with childbearing potential a negative pregnancy test must be obtained.
  • Any psycho-social condition hampering compliance with the study protocol.
  • MGMT promoter methylation status equivocal.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (actual)

Study arms

  • Experimental
    Experimental intervention

    Fluorescence-guided surgery (day 0) Leukapheresis (wk4) Fractionated radiotherapy (60 Gy: 2 Gy/d, 5/7 d, 6 wks; wk5 10) and concomitant TMZ chemotherapy (75 mg/m2/d; 6 wks; wk5-10) vaccination with autologous, tumor lysate-loaded, mature dendritic cells (DC) (7x, 2 - 10 x 106 DC each, intradermal injection, weekly wk11-14, wk17, 21, 25)Adjuvant TMZ chemotherapy (150-200 mg/m2/d, 6x, days 1 5 of 28 d cycle: wk15, 19, 23, 27, 31, 35)

    Biological: Autologous, tumor lysate-loaded, mature dendritic cells (DC)

  • Other
    Control intervention

    Standard therapy: Fluorescence-guided surgery (day 0) Fractionated radiotherapy (60 Gy: 2 Gy/d, 5/7 d, 6 wks; wk5 10) and concomitant TMZ chemotherapy (75 mg/m2/d; 6 wks; wk5-10) Adjuvant TMZ chemotherapy (150-200 mg/m2/d, 6x, days 1 5 of 28 d cycle: wk15, 19, 23, 27, 31, 35)

    Drug: standard therapy

Interventions

  • BiologicalAutologous, tumor lysate-loaded, mature dendritic cells (DC)

    Advanced therapy medicinal product (ATMP) produced at the University Hospital Düsseldorf according to Good Manufacturing Practice (GMP) with production permission according §13 AMG (German Drug Law) of the local authorities (Bezirks¬regierung Düsseldorf)

    Also known as: dendritic cell vaccination

  • Drugstandard therapy

    temozolomide, fractionated radiochemotherapy

    Also known as: temozolomide, fractionated radiochemotherapy

06

What researchers measure

Primary outcomes

  1. Overall survival (OS)

    Overall survival as measured from the day of surgery until death from any cause assessed up to 34 months

    Time frame: Day of surgery until death of any cause assessed up to 34 months

Secondary outcomes

  1. Progression free survival (PFS)

    Progression-free survival as measured from the day of surgery until diagnosis of tumor progression by MRI scan according to modified Response Assessment in Neuro-Oncology (RANO) criteria assessed up to 34 months

    Time frame: Day of surgery until day of diagnosis of tumor progression assessed upto 34 months

  2. OS rates

    OS rates at 6, 12 and 24 months after the day of surgery

    Time frame: 6, 12 and 24 months after the day of surgery

  3. PFS rates

    PFS rates at 6, 12 and 24 months after the day of surgery

    Time frame: 6, 12 and 24 months after the day of surgery

  4. Frequency and severity of adverse events

    Safety based on the frequency and severity of adverse events (AE) with toxicity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events 4.03 (CTCAE 4.03)

    Time frame: 34 months

  5. Karnofsky Performance Status

    Overall and neurological performance based on the Karnofsky performance status (MMSE-2)

    Time frame: 34 months

  6. MMSE-2

    Overall and neurological performance based on the Minimal Mental State Examination 2 (MMSE-2)

    Time frame: 34 months

  7. Quality of life of cancer patients

    Quality of life as determined by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 3.0

    Time frame: 34 months

  8. Quality of life in patients with brain cancer

    Quality of life as determined by the European Organization for Research and Treatment of Cancer (EORTC) Brain Cancer Module QLQ-BN20

    Time frame: 34 months

  9. Psychological distress in oncology patients

    Quality of life as determined by the Distress Thermometer (DT)

    Time frame: 34 months

  10. Psychological distress, anxiety and depression

    Quality of life as determined by the Hospital Anxiety and Depression Scale (HADS) for psycho-oncological strain assessment

    Time frame: 34months

07

Study locations

6 sites
  • Klinik für Neurologie, Knappschaftskrankenhaus Bochum
    Bochum, North Rhine-Westphalia 44829, Germany
  • Klinik für Neurochirurgie, Sana Kliniken Duisburg
    Duisburg, North Rhine-Westphalia 47055, Germany
  • Neurochirurgische Klinik, Universitätsklinikum Düsseldorf
    Düsseldorf, North Rhine-Westphalia 40225, Germany
  • St. Marien Hospital Lünen, Klinik für Neurochirurgie
    Lünen, North Rhine-Westphalia 44534, Germany
  • Klinik für Allgemeine Neurologie, Universitätsklinikum Münster
    Münster, North Rhine-Westphalia 48149, Germany
  • Helios Klinikum Krefeld, Klinik für Neurochirurgie
    Krefeld, 47805, Germany
08

References and documents

Publications

  • Naulaerts S, Datsi A, Borras DM, Antoranz Martinez A, Messiaen J, Vanmeerbeek I, Sprooten J, Laureano RS, Govaerts J, Panovska D, Derweduwe M, Sabel MC, Rapp M, Ni W, Mackay S, Van Herck Y, Gelens L, Venken T, More S, Bechter O, Bergers G, Liston A, De Vleeschouwer S, Van Den Eynde BJ, Lambrechts D, Verfaillie M, Bosisio F, Tejpar S, Borst J, Sorg RV, De Smet F, Garg AD. Multiomics and spatial mapping characterizes human CD8+ T cell states in cancer. Sci Transl Med. 2023 Apr 12;15(691):eadd1016. doi: 10.1126/scitranslmed.add1016. Epub 2023 Apr 12. PubMed 37043555 ↗
  • Rapp M, Grauer OM, Kamp M, Sevens N, Zotz N, Sabel M, Sorg RV. A randomized controlled phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy of newly diagnosed glioblastoma (GlioVax): study protocol for a randomized controlled trial. Trials. 2018 May 25;19(1):293. doi: 10.1186/s13063-018-2659-7. PubMed 29801515 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for May 2027, 110 months after the start.

Of 186 non-industry phase 2 interventional studies under Glioblastoma, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 88. This study's planned 110 months is above that.

Counting every sponsor, half of 237 studies reached it within 56 months; a quarter within 41 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2017
First posted
Jan 10, 2018
StartActual
Mar 6, 2018
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Dec 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03395587
Lead sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
German Federal Ministry of Education and Research
Responsible party
Sponsor
First posted
Jan 10, 2018
Start date
Mar 6, 2018
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Dec 2, 2024

Study contacts

Michael Sabel, Prof. MD
principal investigator · Department of Neurosurgery

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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