Dendritic Cell Cancer Vaccine for High-grade Glioma (GBM-Vax)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Activartis Biotech
ClinicalTrials.gov Identifier:
NCT01213407
First received: May 28, 2010
Last updated: May 18, 2016
Last verified: May 2016
  Purpose
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 therapy with Temozolomide and radiotherapy only; after tumour resection of at least 70% in both groups. The hypothesis is based on the assumption that time to progression will be doubled in the treatment group.

Condition Intervention Phase
Glioblastoma Multiforme
Drug: Trivax, Temozolomide, Surgery, Radiotherapy
Drug: Temozolomide, Surgery, Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: First Line Standard Therapy of Glioblastoma Multiforme With or Without add-on Treatment With Trivax, an Anti-tumour Immune Therapy Based on Tumour-lysate Charged Dendritic Cells

Resource links provided by NLM:


Further study details as provided by Activartis Biotech:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Progression free survival measured as percentage of non-progressive patients with newly diagnosed GBM 12 months after a post-operative MRI scan treated according to the current standard (surgical resection, irradiation, oral chemotherapy with Temozolomide), and Trivax, an autologous DC cancer vaccine charged with autologous tumour protein, as add-on therapy (group A), in comparison to patients receiving standard treatment without Trivax (group B).


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Quality of life in patients treated with Trivax as an add-on therapy using ECOG (Eastern Cooperative Oncology Group) performance status compared to quality of life of patients receiving standard therapy.

  • Progression free survival at 18 and 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Progression free survival measured as percentage of non-progressive patients at 18 and 24 months post initiation of treat-ment.

  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The percentage of survival will be assessed at 12, 18, and 24 months.


Enrollment: 87
Study Start Date: April 2010
Study Completion Date: November 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard therapy plus Trivax
Standard therapy with Surgery, Temozolomide, and Radiotherapy; plus Trivax, 5x10e6 autologous interleukine-12 secreting dendritic cells charged with autologous tumour lysate.
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.

Active Comparator: Standard therapy
Surgery, Temozolomide, Radiotherapy
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


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213407

Locations
Austria
Landesnervenklinik Wagner-Jauregg
Linz, Oberösterreich, Austria, 4020
Landeskrankenhaus Feldkirch
Feldkirch, Austria, 6807
Department of Neurosurgery, Medical University Graz
Graz, Austria, 8036
Clinical Department of Neurology, Medical University Innsbruck
Innsbruck, Austria, 6020
Department of Neurosurgery, Christian Doppler Klinik, Paracelsus Medizinische Privatuniversität
Salzburg, Austria, 5020
Neuroonkologisches Tumorboard KFJ-KA; Rudolfsstiftung
Vienna, Austria, 1030
Department of Paediatrics, Medical University Vienna
Vienna, Austria, 1090
Medical Department of Oncology, Donauspital, SMZ-Ost
Vienna, Austria, 1220
Sponsors and Collaborators
Activartis Biotech
Investigators
Principal Investigator: Johanna Buchroithner, MD Landesnervenklinik Wagner-Jauregg
  More Information

Publications:
Responsible Party: Activartis Biotech
ClinicalTrials.gov Identifier: NCT01213407     History of Changes
Other Study ID Numbers: GBM-Vax-TRX2 
Study First Received: May 28, 2010
Last Updated: May 18, 2016
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Activartis Biotech:
Dendritic cell
Cancer vaccine
Anti-tumor immune therapy
Interleukine-12
Individualised autologous therapy
Brain cancer
Temozolomide
Radiotherapy
Irradiation
High-grade glioma
Advanced therapy medicinal product ATMP
Somatic cell therapy
Leukocyte apheresis
Neurosurgery
Neurooncology
Neurology
Immunology
Tumor immunology
Transfusion medicine
Monocyte
Killer cell
Cytotoxic T-cell
Cytotoxic T-lymphocyte

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2016