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
Recruitment status was Recruiting
Sponsor:
Trimed Biotech GmbH
Information provided by:
Trimed Biotech GmbH
ClinicalTrials.gov Identifier:
NCT01213407
First received: May 28, 2010
Last updated: October 1, 2010
Last verified: October 2010
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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
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 | |
| 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 | |
| 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 | |
| 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:
|
Cancer vaccine Anti-tumor immune therapy Brain cancer Tumor immunology Dendritic cell Interleukine-12 Individualised autologous therapy Temozolomide Radiotherapy Irradiation High-grade glioma Advanced therapy medicinal product ATMP |
Somatic cell therapy Leukocyte apheresis Neurosurgery Neurooncology Neurology Immunology Transfusion medicine Monocyte Killer cell Cytotoxic T-cell Cytotoxic T-lymphocyte |
Additional relevant MeSH terms:
|
Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Glioblastoma Astrocytoma Glioma Temozolomide Dacarbazine Interleukin-12 |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Adjuvants, Immunologic Immunologic Factors |
ClinicalTrials.gov processed this record on May 21, 2013