GlioblastomaPhase 1/2NCT00846456
Safe Study of Dendritic Cell (DC) Based Therapy Targeting Tumor Stem Cells in Glioblastoma
A Phase 1/2 study testing Dendritic cell vaccine with mRNA from tumor stem cells in people with Glioblastoma and Brain Tumor, run by Oslo University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma, Brain Tumor
- What is being tested?
- Dendritic cell vaccine with mRNA from tumor stem cells
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Feb 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
About this study
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
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.
- Conditions
- Glioblastoma, Brain Tumor
- Being tested
- Dendritic cell vaccine with mRNA from tumor stem cells
- Keywords
- Tumor setm cell
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic cell vaccine with mRNA from tumor stem cellsBiological
Intradermal injection of transfected dendritic cells
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: During follow-up
Secondary outcomes (1)
Evaluation of immunological response, time to disease progression and survival time
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steinar Aamdal, Oslo University Hospital
- Investigators
- Steinar Aamdal, MD, PhD, Principal investigator, Department of Clinical Cancer Research, RikshospitaletIver A Langmoen, MD, PhD, Study director, Dept of Neurosurgery, Ulleval University HospitalGunnar Kvalheim, MD, PhD, Study director, Dept of cellular therapy, Rikshospitalet HFGustav Gaudernack, PhD, Study director, Inst. of Immunotherapy, Rikshospitalet HFKnut Lote, MD, PhD, Study director, Dept. of oncology, Rikshospitalet HFJon Berg-Johnsen, MD, PhD, Study director, Dept. of Neurosurgery, Rikshospitalet HFCarl Langberg, MD, PhD, Study director, Dept of oncology, Ulleval University HospitalMarta Nyakas, MD, Study director, Dept. of Clinical Cancer Research, Rikshospitalet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846456
- Sponsor's protocol ID
- DC-CAST-GBM
- Status last verified
- Oct 2015
- First submitted
- 15 Feb 2009
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23817721
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00846456
- Acronym / sponsor ID
- DC-CAST-GBM
- Conditions
- Glioblastoma, Brain Tumor
- Keywords
- Tumor setm cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dendritic cell vaccine with mRNA from tumor stem cellsIntradermal injection of transfected dendritic cells | Biological | – |
Primary outcome
Adverse events
Time frame: During follow-up
1 secondary outcome
Evaluation of immunological response, time to disease progression and survival time
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Derived from this study: PubMed 23817721Vik-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.
Related trials for Glioblastoma
RecruitingPhase 1
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
Glioblastoma Multiforme, Recurrent Glioblastoma
RecruitingPhase 1
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
Adult Glioblastoma, High Grade Glioma
Not yet recruitingPhase 1
IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)
High-grade Glioma, Diffuse Intrinsic Pontine Glioma
Not yet recruitingPhase 1
Immune Modulatory DC Vaccine Against Brain Tumor
Diffuse Intrinsic Pontine Glioma or Glioblastoma
Recruiting
Tear Fluid for the Detection of Tumor-associated Extracellular Vesicles in Glioblastoma Patients
Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steinar Aamdal, MD, PhD principal investigator
Department of Clinical Cancer Research, Rikshospitalet
Iver A Langmoen, MD, PhD study director
Dept of Neurosurgery, Ulleval University Hospital
Gunnar Kvalheim, MD, PhD study director
Dept of cellular therapy, Rikshospitalet HF
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dendritic cell vaccine with mRNA from tumor stem cells in people with Glioblastoma and Brain Tumor, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: During follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00846456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.