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
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring Tumor setm cell
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.
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
No
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:
First Name & Middle Initial & Last Name & Degree
Steinar Aamdal, MD, PhD
Organizational Affiliation
Department of Clinical Cancer Research, Rikshospitalet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iver A Langmoen, MD, PhD
Organizational Affiliation
Dept of Neurosurgery, Ulleval University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gunnar Kvalheim, MD, PhD
Organizational Affiliation
Dept of cellular therapy, Rikshospitalet HF
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gustav Gaudernack, PhD
Organizational Affiliation
Inst. of Immunotherapy, Rikshospitalet HF
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Knut Lote, MD, PhD
Organizational Affiliation
Dept. of oncology, Rikshospitalet HF
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jon Berg-Johnsen, MD, PhD
Organizational Affiliation
Dept. of Neurosurgery, Rikshospitalet HF
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carl Langberg, MD, PhD
Organizational Affiliation
Dept of oncology, Ulleval University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marta Nyakas, MD
Organizational Affiliation
Dept. of Clinical Cancer Research, Rikshospitalet HF
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Einar O Vik-Mo, MD
Organizational Affiliation
Dept of Neurosurgery, Ulleval University Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23817721
Citation
Vik-Mo EO, Nyakas M, Mikkelsen BV, Moe MC, Due-Tonnesen P, Suso EM, Saeboe-Larssen S, Sandberg C, Brinchmann JE, Helseth E, Rasmussen AM, Lote K, Aamdal S, Gaudernack G, Kvalheim G, Langmoen IA. Therapeutic vaccination against autologous cancer stem cells with mRNA-transfected dendritic cells in patients with glioblastoma. Cancer Immunol Immunother. 2013 Sep;62(9):1499-509. doi: 10.1007/s00262-013-1453-3. Epub 2013 Jul 2.
Results Reference
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Safe Study of Dendritic Cell (DC) Based Therapy Targeting Tumor Stem Cells in Glioblastoma
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