Safe Study of Dendritic Cell (DC) Based Therapy Targeting Tumor Stem Cells in Glioblastoma
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Steinar Aamdal, Oslo University Hospital
First received: February 15, 2009
Last updated: February 6, 2013
Last verified: February 2013
The study induces an immune response towards the stem-cell like part of glioblastomas in combination with standard therapy. The aim is to define and characterize the feasibility, potential adverse effects of such therapy and measure time to progression and survival.
Biological: Dendritic cell vaccine with mRNA from tumor stem cells
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I/II Trial of Vaccine Therapy With Tumor Stem Cell Derived mRNA- Transfected Dendritic Cells in Patients Receiving Standard Therapy for Glioblastoma
Primary Outcome Measures:
- Adverse events [ Time Frame: During follow-up ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Evaluation of immunological response, time to disease progression and survival time [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Accessible volume and quality of tumor tissue for vaccine production
- MRI after surgery with minimal tumor remnant.
- Between 18 and 70 years of age.
- Must have histologically confirmed glioma grade IV, and a candidate for combined radiation therapy and chemotherapy ("Stupps regimen").
- Must be ambulatory with a ECOG performance status 0 or 1.
- A minimum 4 weeks must have elapsed between the end of glucocorticoid treatment and beginning of vaccination.
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented.
- Tumor in a localization where a modest increase in size due to reactive oedema may have a large impact on patients neurological condition.
- Large tumor remnant after surgery.
- History of prior malignancy other than glioma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervicis stage IB.
- Chronic active infection requiring antibiotic therapy.
- Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
- Prior splenectomy.
- Glucocorticoid treatment not possible to terminate due to autoimmune disease or increased intracranial pressure.
- Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
- History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis- dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
- Chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination.
- Pregnancy or lactation.
- Any reason why, in the opinion of the investigator, the patient should not participate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846456
Oslo University Hospital
||Steinar Aamdal, MD, PhD
||Department of Clinical Cancer Research, Rikshospitalet
||Iver A Langmoen, MD, PhD
||Dept of Neurosurgery, Ulleval University Hospital
||Gunnar Kvalheim, MD, PhD
||Dept of cellular therapy, Rikshospitalet HF
||Gustav Gaudernack, PhD
||Inst. of Immunotherapy, Rikshospitalet HF
||Knut Lote, MD, PhD
||Dept. of oncology, Rikshospitalet HF
||Jon Berg-Johnsen, MD, PhD
||Dept. of Neurosurgery, Rikshospitalet HF
||Carl Langberg, MD, PhD
||Dept of oncology, Ulleval University Hospital
||Marta Nyakas, MD
||Dept. of Clinical Cancer Research, Rikshospitalet HF
||Einar O Vik-Mo, MD
||Dept of Neurosurgery, Ulleval University Hospital
No publications provided by Oslo University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Vik-Mo EO, Nyakas M, Mikkelsen BV, Moe MC, Due-Tønnesen P, Suso EM, Sæbøe-Larssen S, Sandberg C, Brinchmann JE, Helseth E, Rasmussen AM, Lote K, Aamdal S, Gaudernack G, Kvalheim G, Langmoen IA. Therapeutic vaccination against autologous cancer stem cells with mRNA-transfected dendritic cells in patients with glioblastoma. Cancer Immunol Immunother. 2013 Sep;62(9):1499-509. doi: 10.1007/s00262-013-1453-3. Epub 2013 Jul 2.
||Steinar Aamdal, Oslo University Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 15, 2009
||February 6, 2013
||Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Keywords provided by Oslo University Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue