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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00846456
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Oslo University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Steinar Aamdal, MD, PhDIver A Langmoen, MD, PhDGunnar Kvalheim, MD, PhDGustav Gaudernack, PhDKnut Lote, MD, PhDJon Berg-Johnsen, MD, PhDCarl Langberg, MD, PhDMarta Nyakas, MDEinar O Vik-Mo, MD
Principal Investigator Affiliation Department of Clinical Cancer Research, RikshospitaletDept of Neurosurgery, Ulleval University HospitalDept of cellular therapy, Rikshospitalet HFInst. of Immunotherapy, Rikshospitalet HFDept. of oncology, Rikshospitalet HFDept. of Neurosurgery, Rikshospitalet HFDept of oncology, Ulleval University HospitalDept. of Clinical Cancer Research, Rikshospitalet HFDept of Neurosurgery, Ulleval University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Brain Tumor

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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