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.]

NCT02649582 : Adjuvant Dendritic Cell-immunotherapy Plus Temozolomide in Glioblastoma Patients
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Newly diagnosed, histologically verified glioblastoma (WHO grade IV)

- Aged = 18 years

- Total or subtotal resection:

- Total resection: macroscopic complete resection as assessed by the neurosurgeon
and absence of any residual contrast-enhancing mass on post-operative (= 72h)
brain MRI

- Subtotal resection: macroscopic complete resection as assessed by the
neurosurgeon, but with residual contrast-enhancement = 2 cm³ on post-operative (=
72h) brain MRI

- Signed informed consent

- Willing and able to comply with the protocol as judged by the Investigator

- Estimated to start with chemoradiation = 28 days and = 49 days following surgical
resection

- Adequate hematologic, renal, and hepatic function at time of screening:

- Hemoglobin = 10 g/dL (transfusion is allowed to maintain or exceed this level)

- Monocyte count (Mo) = 0.2 x 10^9/L

- Absolute neutrophil count (ANC) = 1.0 x 10^9/L

- Platelet count (PLT) = 100 x 10^9/L

- Serum creatinine = 1.5 x the upper limit of normal (ULN)

- Liver-function values < 3 x ULN

- No corticosteroid treatment = 1 week before apheresis

- WHO performance status = 2

- Life expectancy = 3 months as estimated by the Investigator

Exclusion Criteria:

- History of another malignancy, except for adequately controlled basal cell skin
carcinoma, squamous skin carcinoma, or carcinoma in situ of the uterine cervix

- Prior radiation or chemotherapy

- Any pre-existing contraindication for temozolomide treatment

- Any pre-existing contraindication for contrast-enhanced brain MRI

- Pregnant or breast-feeding

- Documented immune deficiency or systemic immune-suppressive treatment

- Positive viral serology for HIV, HBV, HCV, or syphilis at time of screening

- Any other condition, either physical or psychological, or reasonable suspicion thereof
on clinical or special investigation, which contraindicates the use of the vaccine, or
may negatively affect patient compliance, or may place the patient at higher risk of
potential treatment complications
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02649582      |      Link to official Clinicaltrials.gov listing
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