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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Trimed Biotech GmbH.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Trimed Biotech GmbH
ClinicalTrials.gov Identifier:
NCT01213407
First received: May 28, 2010
Last updated: October 1, 2010
Last verified: October 2010
  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 Trimed Biotech GmbH:

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 (for study patients older 18 years).

  • 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.


Estimated Enrollment: 56
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: March 2011 (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.

Other Name: Temodal
Active Comparator: Standard therapy
Surgery, Temozolomide, Radiotherapy
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.

Other Name: Temodal
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

Other Name: Temodal

  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

Contacts
Contact: Thomas Felzmann, MD, MBA +431 40170 ext 4080 thomas.felzmann@ccri.at

Locations
Austria
Landesnervenklinik Wagner-Jauregg Recruiting
Linz, Oberösterreich, Austria, 4020
Contact: Johanna Buchroithner, MD    +43 (0)50 554/62 ext 25921    johanna.buchroithner@gespag.at   
Contact: Josef Pichler, MD    +43 (0)50 554/62 ext 28556    interneambulanz.wj@gespag.at   
Principal Investigator: Johanna Buchroithner, MD         
Landeskrankenhaus Feldkirch Recruiting
Feldkirch, Austria, 6807
Contact: Karl Roessler, MD    +43 5522 / 303 ext 1901    karl.roessler@lkhf.at   
Principal Investigator: Karl Rössler, MD         
Medical University Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Günther Stockhammer, MD    +43-512-504 ext 24368    guenther.stockhammer@i-med.ac.at   
Principal Investigator: Günther Stockhammer, MD         
Donauspital, SMZ-Ost Recruiting
Vienna, Austria, 1220
Contact: Reinhard Ruckser, MD    +431 288 02 ext 3214    reinhard.ruckser@wienkav.at   
Contact: Elvira Kitzweger    +431 288 02 ext 3280    elvira.kitzweger@wienkav.at   
Principal Investigator: Reinhard Ruckser, MD         
Kaiser Franz-Josef Spital Recruiting
Vienna, Austria, 1100
Contact: Stefan Oberndorfer, MD    +431 601 91 ext 2061    stefan.oberndorfer@wienkav.at   
Contact: Günther Kleinpeter, MD    +431 711 65 ext 4301    guenther.kleinpeter@wienkav.at   
Principal Investigator: Stefan Oberndorfer, MD         
Medical University Vienna Recruiting
Vienna, Austria, 1090
Contact: Christine Marosi, MD    +431 40400 ext 4447    christine.marosi@meduniwien.ac.at   
Contact: Cornelia Sax, MSc    +431 40400 ext 4421    cornelia.sax@meduniwien.ac.at   
Principal Investigator: Christine Marosi, MD         
Sponsors and Collaborators
Trimed Biotech GmbH
Investigators
Principal Investigator: Johanna Buchroithner, MD Landesnervenklinik Wagner-Jauregg
  More Information

Additional Information:
Publications:
Responsible Party: Thomas Felzmann, Trimed Biotech GmbH
ClinicalTrials.gov Identifier: NCT01213407     History of Changes
Other Study ID Numbers: GBM-Vax
Study First Received: May 28, 2010
Last Updated: October 1, 2010
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Trimed Biotech GmbH:
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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014