We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Safe Study of Dendritic Cell (DC) Based Therapy Targeting Tumor Stem Cells in Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00846456
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : October 20, 2015
Information provided by (Responsible Party):
Steinar Aamdal, Oslo University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Brain Tumor Biological: Dendritic cell vaccine with mRNA from tumor stem cells Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Vaccine Therapy With Tumor Stem Cell Derived mRNA- Transfected Dendritic Cells in Patients Receiving Standard Therapy for Glioblastoma
Study Start Date : January 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Intervention Details:
  • Biological: Dendritic cell vaccine with mRNA from tumor stem cells
    Intradermal injection of transfected dendritic cells

Primary Outcome Measures :
  1. Adverse events [ Time Frame: During follow-up ]

Secondary Outcome Measures :
  1. Evaluation of immunological response, time to disease progression and survival time [ Time Frame: 5 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846456

Sponsors and Collaborators
Oslo University Hospital
Layout table for investigator information
Principal Investigator: Steinar Aamdal, MD, PhD Department of Clinical Cancer Research, Rikshospitalet
Study Director: Iver A Langmoen, MD, PhD Dept of Neurosurgery, Ulleval University Hospital
Study Director: Gunnar Kvalheim, MD, PhD Dept of cellular therapy, Rikshospitalet HF
Study Director: Gustav Gaudernack, PhD Inst. of Immunotherapy, Rikshospitalet HF
Study Director: Knut Lote, MD, PhD Dept. of oncology, Rikshospitalet HF
Study Director: Jon Berg-Johnsen, MD, PhD Dept. of Neurosurgery, Rikshospitalet HF
Study Director: Carl Langberg, MD, PhD Dept of oncology, Ulleval University Hospital
Study Director: Marta Nyakas, MD Dept. of Clinical Cancer Research, Rikshospitalet HF
Study Director: Einar O Vik-Mo, MD Dept of Neurosurgery, Ulleval University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Steinar Aamdal, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00846456    
Other Study ID Numbers: DC-CAST-GBM
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Keywords provided by Steinar Aamdal, Oslo University Hospital:
Tumor setm cell
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue