Clinical Trial Details
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NCT01006044 : Efficacy & Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme After Complete Surgical Resection
PhasePhase 2
AgesMin: 18 Years Max: 70 Years
Inclusion Criteria:

- Patients with histological diagnosis of glioblastoma that have not received any
previous chemotherapy or radiotherapy treatment.

- Patients are able to give informed consent and willing to comply with the protocol
requirements during the study period.

- Age between 18 and 70 years

- Negative pregnancy test In female fertile subjects

- Patient is, in the investigator's opinion, willing and able to comply with the
protocol requirements.

- Complete/Total resection of tumour with surgery guided by fluorescence microscopy and
5-aminolevulinic acid, observed with post operative magnetic resonance imaging. The
residual lesion must be null or ? 1 cm3 by contrast capturing.

- Enough tumor tissue available for the cellular vaccine elaboration

Exclusion Criteria:

- Patients with infections, severe diseases or hepatic, renal or medullary failures,
that in the investigator's opinion, are not eligible to participate in the study.

- Participation in other clinical trial. If the patient has participated in other
clinical trial within previous months, the patient has to complete the washout period
required by de the investigator.

- Patients with diagnosis of other neoplasia, except basal cell or squamous cell skin,
carcinoma in situ of the cervix properly treated or other tumour curatively treated
and no evidence of relapse for at least 3 years. Those cases with coexisting tumours
of long-term survival prediction will be considered individually.

- Pregnant or breast-feeding women.

- Patients who need immunosuppressive drugs.

- Positive serology for HIV , hepatitis B (HBsAg) or hepatitis C virus.

- Impossible to get enough material for at least 6 cellular vaccine production.

- Absolute contraindication for the patient to receive other steps of standard
treatment of glioblastoma (surgery, radio and chemotherapy)
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