Status:
COMPLETED
Dendritic Cell Cancer Vaccine for High-grade Glioma
Lead Sponsor:
Activartis Biotech
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
3-70 years
Phase:
PHASE2
Brief Summary
A randomised, open-label, 2-arm, multi-centre, phase II clinical study with one group receiving standard therapy with Temozolomide, radiotherapy, and Trivax; and a control group receiving standard the...
Detailed Description
Vaccination represents a success story in modern medicine and its principles have been found to be valid in different species, at least in the case of infectious diseases. As of today, there is little...
Eligibility Criteria
Inclusion
- Female or male, paediatric or adult patients of 3 to 70 years of age at time of diagnosis that qualify for standard treatment including surgery, Temozolomide and radiotherapy.
- GBM (WHO IV), confirmed by histology.
- Total, subtotal, or partial resection of more then 70% of tumour mass defined by MRI.
- Supratentorial tumour localisation.
- ECOG performance status 0, 1, or 2 (for study patients older 18 years).
- Life expectancy of at least 12 weeks by assessment of the attending physician.
- Written informed consent of patient and/or legal guardian in case of children or adolescents.
Exclusion
- Less than 100 µg of tumour protein obtained from the resected tissue.
- Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the study, e.g. in another therapeutic phase I, II, or III study.
- Positive pregnancy test or breast-feeding.
- Patients unwilling to perform a save method of birth control.
- Known hypersensitivity to temozolomide.
- HIV positivity.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01213407
Start Date
April 1 2010
End Date
November 1 2015
Last Update
May 19 2016
Active Locations (8)
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1
Landesnervenklinik Wagner-Jauregg
Linz, Upper Austria, Austria, 4020
2
Landeskrankenhaus Feldkirch
Feldkirch, Austria, 6807
3
Department of Neurosurgery, Medical University Graz
Graz, Austria, 8036
4
Clinical Department of Neurology, Medical University Innsbruck
Innsbruck, Austria, 6020