Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03548571 : Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy
PhasePhase 2/Phase 3
AgesMin: 18 Years Max: 70 Years
Eligibility
Inclusion Criteria:

All of the following conditions must apply:

- Must be at least 18 years and less than 70 years of age.

- Must be ambulatory with a ECOG performance status 0 or 1

- Must have histologically confirmed glioblastoma IDH wild-type, with unmethylated
MGMT-gene promotor, and a candidate for combined radiation therapy and chemotherapy
("Stupps Regimen").

- Must have accessible volume and quality of tumor tissue for vaccine production
(proliferation of cells and extraction of tumor mRNA) at first surgery.

- Must have postoperative MRI after surgery with contrast enhancing tumor remnant of
less than 1 cm3 or less than 10% of original tumor volume.

- Normal organ function defined by laboratory values as following: ANC > 1.5 x 109/L;
platelets >100 x109/L, Hb >9g/dL (> 5.6 mmol/L). Creatinine < 140 µmol/L (1.6 mg/dL);
if borderline, the creatinine clearance >40 mL/min, Bilirubin < 20% above the upper
limit of normal, ASAT and ALAT < 2.5 the upper limit of normal. Albumin >2.5 g/L.

- Serology indicating contagious HIV, HBV, HCV and Treponema pallidum must be negative.

- Signed informed consent and expected cooperation of the patients for the treatment and
follow up must be obtained and documented according to ICH GCP, and national/local
regulations.

Exclusion Criteria:

- Tumor in a localization where a modest increase in size due to reactive oedema may
have a large impact on the patient's neurological condition, i.e. brain stem.

- History of prior malignancy other than glioblastoma, with the exception of curatively
treated basal cell or squamous cell carcinoma of the skin and ca. cervicis stage IB.

- Active infection requiring antibiotic therapy.

- Significant cardiac or other medical illness that would limit activity or survival,
such as severe congestive heart failure, unstable angina, or serious cardiac
arrhythmia.

- Prior splenectomy.

- Glucocorticoid treatment not possible to terminate due to autoimmune disease or
increased intracranial pressure.

- Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.

- History of immunodeficiency or autoimmune disease such as rheumatoid arthritis,
systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile
onset insulin dependent diabetes, or a vasculitic syndrome.

- Chemotherapy or other potentially immune-suppressive therapy outside protocol that has
been administered within the last 4 weeks prior to vaccination.

- Positive pregnancy test in women of childbearing potential (within 7 days before the
first vaccination). Women of childbearing potential and sexually active male
participants must use reliable methods of contraception during the whole treatment
period and 3 months after the last trial drug dose. Reliable methods of contraception
are defined in section .

- Any reason why, in the opinion of the investigator, the patient should not
participate.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03548571      |      Link to official Clinicaltrials.gov listing
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