Efficacy of Zoster Vaccination in Glioblastoma Patients

Korábbi kezelés

• 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
• Known or persistent abuse of medication, drugs or alcohol

Más betegség

• 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
• Contraindications for radiotherapy (including active inflammatory disease)
• Known hypersensitivity against vaccine contra herpes zoster, or its constituents
• Synchronous secondary malignancy
• Patients with clinically significant liver-, renal- or blood disorder
• Patients with known additional significant neurological disease (e.g. primary seizure disorder*, de-mentia, progressive degenerative neurological disease, meningitis or encephalitis, hydrocephalus with increased intracranial pressure)
• Patients with brain tumor-related epilepsy, seizure-free under antiepileptic therapy are eligible
• Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators and programmable shunts) or documented clinically signifi- cant arrhythmias
• History of HIV infection

Laborértékek

• Significant comorbidities at baseline, which would prevent possible chemotherapy, including:
  • 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

Egyéb

• Subjects will not be included in the study if any of the following criteria apply. General Exclusion Criteria:
• 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
• Gliomatosis cerebri at time of enrollment on any imaging or proved by histopathology
• 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
  • Indication-specific exclusion criteria in order to guarantee the highest degree of safety of all treatment procedures from a medical point of view:
• Primary infra-tentorial located glioblastoma (justification: specific subgroup of patients with different prognosis)

• Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
• 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