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

October 19, 2015 updated by: Steinar Aamdal, Oslo University Hospital

Phase I/II Trial of Vaccine Therapy With Tumor Stem Cell Derived mRNA- Transfected Dendritic Cells in Patients Receiving Standard Therapy for Glioblastoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: During follow-up
During follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 15, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC-CAST-GBM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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