Dendritic Cell Cancer Vaccine for High-grade Glioma

PHASE2CompletedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

June 30, 2015

Study Completion Date

November 30, 2015

Conditions
Glioblastoma Multiforme
Interventions
DRUG

Trivax, Temozolomide, Surgery, Radiotherapy

"Trivax: 5 x 10e6 dendritic cells, intranodal in 500 µl NaCl, weeks 7, 8, 9, 10, 12, 16, 20, 24, 28, 32~Irradiation: 2 Gy per fraction once daily, five days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6, total dose 60 Gy~Temozolomide concomitant to radiotherapy: 75 mg/m²/day, 5 days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6.~Break: weeks 7, 8, 9, 10.~Temozolomide adjuvant: 150 mg/m²/day, five days per week (Mo-Fr), week 11; 200 mg/m²/day, five days per week (Mo-Fr), weeks 15, 19, 23, 27, 31."

DRUG

Temozolomide, Surgery, Radiotherapy

"Irradiation: 2 Gy per fraction once daily, five days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6, total dose 60 Gy~Temozolomide concomitant to radiotherapy: 75 mg/m²/day, 5 days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6~Break: weeks 7, 8, 9, 10~Temozolomide adjuvant: 150 mg/m²/day, five days per week (Mo-Fr), week 11; 200 mg/m²/day, five days per week (Mo-Fr), weeks 15, 19, 23, 27, 31"

Trial Locations (8)

1030

Neuroonkologisches Tumorboard KFJ-KA; Rudolfsstiftung, Vienna

1090

Department of Paediatrics, Medical University Vienna, Vienna

1220

Medical Department of Oncology, Donauspital, SMZ-Ost, Vienna

4020

Landesnervenklinik Wagner-Jauregg, Linz

5020

Department of Neurosurgery, Christian Doppler Klinik, Paracelsus Medizinische Privatuniversität, Salzburg

6020

Clinical Department of Neurology, Medical University Innsbruck, Innsbruck

6807

Landeskrankenhaus Feldkirch, Feldkirch

8036

Department of Neurosurgery, Medical University Graz, Graz

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Activartis Biotech

INDUSTRY