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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steinar Aamdal, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00846456
First received: February 15, 2009
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Glioblastoma
Brain Tumor
Biological: Dendritic cell vaccine with mRNA from tumor stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

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 ]

Enrollment: 20
Study Start Date: January 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Dendritic cell vaccine with mRNA from tumor stem cells
    Intradermal injection of transfected dendritic cells
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00846456

Sponsors and Collaborators
Oslo University Hospital
Investigators
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
  More Information

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steinar Aamdal, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00846456     History of Changes
Other Study ID Numbers: DC-CAST-GBM
Study First Received: February 15, 2009
Last Updated: June 24, 2014
Health Authority: Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Tumor setm cell

Additional relevant MeSH terms:
Glioblastoma
Neoplasms
Astrocytoma
Glioma
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on November 25, 2014