Back to results

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

Primary Purpose

Glioblastoma, Brain Tumor

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Dendritic cell vaccine with mRNA from tumor stem cells

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Tumor setm cell

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Adverse events

Secondary Outcome Measures

Evaluation of immunological response, time to disease progression and survival time

Full Information

NCT ID

NCT00846456

First Posted

February 15, 2009

Last Updated

October 19, 2015

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00846456

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma, Brain Tumor

Keywords

Tumor setm cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Dendritic cell vaccine with mRNA from tumor stem cells

Intervention Description

Intradermal injection of transfected dendritic cells

Primary Outcome Measure Information:

Title

Adverse events

Time Frame

During follow-up

Secondary Outcome Measure Information:

Title

Evaluation of immunological response, time to disease progression and survival time

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: