Clinical Trial Details
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NCT03395587 : Efficiency of Vaccination With Lysate-loaded Dendritic Cells in Patients With Newly Diagnosed Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
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

- 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

- Written informed consent to participate in study.

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

- 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.
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