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GlioblastomaPhase 2GlioVaxNCT03395587

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

A Phase 2 study testing Autologous, tumor lysate-loaded, mature dendritic cells (DC) and standard therapy in people with Glioblastoma, run by Heinrich-Heine University, Duesseldorf at 6 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Autologous, tumor lysate-loaded, mature dendritic cells (DC) and standard therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
6 sitesGermany
Study dates
6 Mar 2018to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Klinik für Neurologie, Knappschaftskrankenhaus Bochum

    Bochum, North Rhine-Westphalia, 44829

  • Klinik für Neurochirurgie, Sana Kliniken Duisburg

    Duisburg, North Rhine-Westphalia, 47055

  • Neurochirurgische Klinik, Universitätsklinikum Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • Helios Klinikum Krefeld, Klinik für Neurochirurgie

    Krefeld, 47805

  • St. Marien Hospital Lünen, Klinik für Neurochirurgie

    Lünen, North Rhine-Westphalia, 44534

  • Klinik für Allgemeine Neurologie, Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

About this study

Official title: Phase II Trial of Vaccination with Lysate-loaded, Mature Dendritic Cells Integrated Into Standard Radiochemotherapy in Newly Diagnosed Glioblastoma

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.

Conditions
Glioblastoma
Being tested
Autologous, tumor lysate-loaded, mature dendritic cells (DC), standard therapy
Keywords
glioblastoma,, immunotherapy, dendritic cells, vaccination
Medical subject headings
Glioblastoma

What participants receive

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

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

    Also called dendritic cell vaccination

    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)

  • standard therapyDrug

    Also called temozolomide, fractionated radiochemotherapy

    temozolomide, fractionated radiochemotherapy

Study groups in NCT03395587
Study groupRoleWhat they receive
Experimental interventionExperimentalFluorescence-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)
Receives: Biological: Autologous, tumor lysate-loaded, mature dendritic cells (DC)
Control interventionOtherStandard 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)
Receives: Drug: standard therapy

What is being measured

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

  1. Overall survival (OS)

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

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

Secondary outcomes (10)

  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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 34 months

  5. Karnofsky Performance Status

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

    Measured: 34 months

  6. MMSE-2

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

    Measured: 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

    Measured: 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

    Measured: 34 months

  9. Psychological distress in oncology patients

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

    Measured: 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

    Measured: 34months

Timeline

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

  1. First posted10 Jan 2018
  2. Study start6 Mar 2018
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

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
Randomised
Intervention model
Parallel groups
Model description
prospective, multicenter, open-label, randomized phase 2 study with two parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03395587
Sponsor's protocol ID
GlioVax
Acronym
GlioVax
Status last verified
Nov 2024
First submitted
26 Oct 2017
Last updated
2 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous, tumor lysate-loaded, mature dendritic cells (DC) and standard therapy in people with Glioblastoma, run by Heinrich-Heine University, Duesseldorf at 6 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 17 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

This study is still under way. Results are not available in the source record yet.

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?

Overall survival (OS) (time frame: Day of surgery until death of any cause assessed up to 34 months). 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 NCT03395587, which also lists 2 linked publications.

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 2 Dec 2024.

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