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

Study Overview
=================
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.

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

Conditions
-----------------
Glioblastoma, Brain Tumor

Intervention / Treatment
-----------------
* Biological: Dendritic cell vaccine with mRNA from tumor stem cells


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Dendritic cell vaccine with mRNA from tumor stem cells|Intradermal injection of transfected dendritic cells|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | During follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of immunological response, time to disease progression and survival time |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tumor setm cell