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

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846456
• Other study ID #: DC-CAST-GBM
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 15, 2009
• Last updated: October 19, 2015
• Start date: January 2009
• Est. completion date: February 2013

Study information

• Verified date: October 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Tumor
• Glioblastoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		During follow-up	Yes
Secondary	Evaluation of immunological response, time to disease progression and survival time		5 years	No