Efficacy of Zoster Vaccination in Glioblastoma Patients

NCT07546669 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 25-12859-BO
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glioblastoma (GBM)

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  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)

• Overall survival

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

Study Arms (2)

Arm A Control Group, standard of care trimodality treatment (neurosurgical resection + R(C)Tx)

ACTIVE COMPARATOR

Standard of care trimodality treatment (neurosurgical resection + R(C)Tx) without additional vaccination

Other: Standard of care treatment without additional vaccination

Arm B, interventional arm, trimodality treatment and vaccination against herpes zoster

EXPERIMENTAL

Trimodality treatment and vaccination against herpes zoster

Biological: Additional vaccination against shingles (herpes zoster)

Interventions

Additional vaccination against shingles (herpes zoster) BIOLOGICAL

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

Arm B, interventional arm, trimodality treatment and vaccination against herpes zoster

Standard of care treatment without additional vaccination OTHER

Standard of care treatment without additional vaccination

Arm A Control Group, standard of care trimodality treatment (neurosurgical resection + R(C)Tx)

Eligibility Criteria

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

You may qualify if:

• 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
• Indication for definitive radiotherapy of glioblastoma or adjuvant radiation therapy of glioblastoma resection cavity according to interdisciplinary tumor board consensus and after radiation oncologists evaluation
• Histopathologically proven glioblastoma
• Incorporation of pre-neurochirurgical /-treatment PET/CT or/ and PET/MRI findings into the radiation therapy plan if patient undergoes PET/CT or/ and PET/MRI

You may not qualify if:

• 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
• Known or persistent abuse of medication, drugs or alcohol
• Contraindications for radiotherapy (including active inflammatory disease)
• Known hypersensitivity against vaccine contra herpes zoster, or its constituents
• Gliomatosis cerebri at time of enrollment on any imaging or proved by histopathology
• Synchronous secondary malignancy
• Current or planned pregnancy or nursing women
• Females of child-bearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contracep- tives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
• Primary infra-tentorial located glioblastoma (justification: specific subgroup of patients with different prognosis)
• Significant comorbidities at baseline, which would prevent possible chemotherapy, including:
• i. Platelet count \< 100/nl ii. Absolute neutrophil count (ANC) \< 1.5/nl iii. AST or ALT \> 3 times the upper limit of normal iv. Total bilirubin above the normal range v. Serum creatinine \> 1.7 mg/dl
• Patients with clinically significant liver-, renal- or blood disorder

Sponsors & Collaborators

• University Hospital, Essen: lead
• Karolinska Institutet: collaborator
• Leiden University Medical Center: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

MeSH Terms

Conditions

Glioblastoma

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

Central Study Contacts

Prof. Dr.med. Guberina

CONTACT

+492017232054; strahlentherapie@uk-essen.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.med.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start (Estimated): January 2, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04