Status:
COMPLETED
Safe Study of Dendritic Cell (DC) Based Therapy Targeting Tumor Stem Cells in Glioblastoma
Lead Sponsor:
Oslo University Hospital
Conditions:
Glioblastoma
Brain Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 eff...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00846456
Start Date
January 1 2009
End Date
February 1 2013
Last Update
October 20 2015
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