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Efficacy of Zoster Vaccination in Glioblastoma Patients

ConditionGlioblastoma (GBM)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Essen

About this trial

In modern practice a trimodality treatment has emerged as standard of care for histologically confirmed glioblastoma.

We hypothesize that the additional vaccination against herpes zoster, after surgical resection followed by irradiation therapy and chemotherapy of patients with glioblastoma will lead to a superior local control, overall and progression free survival. In an additional experimental setting based on patient preference the immunological effectiveness of the adoptive transfer of autologous polyclonal cytomegalovirus (CMV) specific T cells will be examined.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age

Written informed consent of the subject

Life expectancy at least 3 months

Participants of child-bearing age must use effective contraception

Disqualifiers

Subjects not able to give consent

Subject without legal capacity who is unable to understand the nature, scope, significance, and con- sequences of this clinical trial

Simultaneously participation in another clinical trial or participation in any clinical trial involving ad- ministration of an investigational medicinal product within 30 days prior to clinical trial beginning

Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk may confound the trial results or may interfere with the subject's participation in this clinical trial

Trial design

Design model

Parallel

Treatments tested in this trial

  • Additional vaccination against shingles (herpes zoster)

    Biological/Vaccine

    Based on patient-preference patients receive autologous CMV-specific T-cells additionally to vaccination contra herpes zoster after completion of radio(chemo-)therapy. Patients included in the experimental arm shall be HLA typed. Up to 6 intravenous infusions of in vitro-expanded T cells at a dose of 2 × 107 cells/m2 body surface area every 2 to 4 weeks shall be administered after clinical assessment. Patients shall continue standard-of-care treatment with temozolomide if indicated. Where possible, administration of autologous T-cells shall be scheduled to fall between chemotherapy treatment weeks to avoid concurrent infusions

  • Standard of care treatment without additional vaccination

    Other intervention

    Standard of care treatment without additional vaccination

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: Arm A Control Group, standard of care trimodality treatment (neurosurgical resection + R(C)Tx)Active comparator 1 intervention
Group B: Arm B, interventional arm, trimodality treatment and vaccination against herpes zosterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

Time frame
Overall survival defined as time from neurosurgical resection to death of any cause. Study time per subject from enrollment through the end of treatment after a maximum of 12 months (provided that additional CTx consolidation therapy is administered)
2

Overall survival

Time frame
From enrollment through the end of treatment after a maximum of 12 months (provided that additional CTx consolidation therapy is administered)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Essen

Lead sponsor

Karolinska Institutet

Collaborator

Leiden University Medical Center

Collaborator

Universitätsklinikum Hamburg-Eppendorf

Collaborator

Source ClinicalTrials.gov

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