Brain Stem GliomaPhase 1NCT00576641
Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma
A Phase 1 study testing autologous dendritic cells in people with Brain Stem Glioma and Glioblastoma, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of the Dendritic Cell Immunotherapy study for patients with glioblastoma and/or brainstem glioma is to determine whether in patients with malignant brain tumors, dendritic cells injected peripherally can reactivate the immune system against the brain tumor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Stem Glioma, Glioblastoma
- What is being tested?
- autologous dendritic cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Apr 2012
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be HLA -A1 or HLA - A2 positive
- Both male and female of child bearing age must use medically accepted form of birth control
- Confirmed brain stem glioma and glioblastoma with MRI
- Presence of at least one of the antigens by immunohistochemistry
- Karnofsky performance of at least 60%
- On maintenance glucocorticoid therapy at no more 2 mg BID
Show all 10Show fewer
- Hematologic and chemistry profiles within the parameters of the protocol
- Wash ou periods from previous therapies: 6 weeks from nitrosurea, 4 weeks from chemotherapy, 2 weeks after resolution of Grade 3 or 4 toxicity
- Able to sign IRB approved Informed consent
- Three adults will be treated prior to any study agent administration to subjects younger than 18 years of age
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Phase l Trial of Tumor Associated Antigen Pulsed Dendritic Cell Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma
The purpose of the Dendritic Cell Immunotherapy study for patients with glioblastoma and/or brainstem glioma is to determine whether in patients with malignant brain tumors, dendritic cells injected peripherally can reactivate the immune system against the brain tumor.
Read the detailed description
Patients will have their white blood cells removed and grown in culture under conditions to make dendritic cells. Dendritic cells are a small group of cells that belong to the white blood cell population. These cells are responsible for letting the immune system know that something foreign, like bacteria or a tumor, is in the body. Dendritic cells help the body ward off disease by alerting the immune system. In previous clinical trials, brain tumor cells called astrocytoma tumor cells and glioblastoma tumor cells were taken from the tumor that was removed during surgery. The brain tumor cells were then placed into a solution in the laboratory that made them grow. Certain parts of the brain tumor's proteins (peptides) were removed from the growing tumor cells and mixed together with the dendritic cells in the blood taken from a vein. This combination of dendritic cells and brain tumor peptides were injected into the patient's skin, like a vaccination. This process is similar to that used in vaccinations. The patients were given three and four injections of dendritic cells mixed with the tumor peptides over the course of a twenty-eight day period.
In this study, the proteins that are manufactured and known to be associated with brain cancers will be mixed with the dendritic cells obtained during leukopheresis (a procedure in which the dendritic cells are separated from the patients' blood). They will then undergo three vaccinations along with follow up clinic visits (which include evaluations and laboratory tests) to check their status.
The investigators learned that it was possible to generate an immune response in a subset of patients with malignant glioma. In addition, these cells were able to reach the brain and kill brain tumor cells. The survival of patients in this study was prolonged when compared to historical controls. Based on clinical data in subjects with brain tumors, the investigators believe that peripheral injection of dendritic cells will generate a more potent immune response for patients with brain stem gliomas and/or glioblastomas. The investigators hope to determine whether this therapy will translate into a longer survival and better quality of life in these patients in whom survival is measured in months. Through this study the investigators hope to learn more about the role of the body's immune response against cancer and about the use of dendritic cells for immunotherapy. This information may prove useful in the therapy of patients with glioblastoma and/or brainstem gliomas.
- Conditions
- Brain Stem Glioma, Glioblastoma
- Being tested
- autologous dendritic cells
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous dendritic cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | Not described Receives: Biological: autologous dendritic cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety/toxicity of Dendritic cell vaccine, Monitor survival and time to progression and monitor the cellular immune responses.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2010
- Study completionApr 2012
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 Brain Stem GliomaStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surasak Phuphanich, Cedars-Sinai Medical Center
- Investigators
- Surasak Phuphanich, M.D., Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576641
- Sponsor's protocol ID
- 6657
- Status last verified
- Oct 2014
- First submitted
- 18 Dec 2007
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jouanneau E, Black KL, Veiga L, Cordner R, Goverdhana S, Zhai Y, Zhang XX, Panwar A, Mardiros A, Wang H, Gragg A, Zandian M, Irvin DK, Wheeler CJ. Intrinsically de-sialylated CD103(+) CD8 T cells mediate beneficial anti-glioma immune responses. Cancer Immunol Immunother. 2014 Sep;63(9):911-24. doi: 10.1007/s00262-014-1559-2. Epub 2014 Jun 4.
PubMed 24893855
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase l Trial of Tumor Associated Antigen Pulsed Dendritic Cell Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma
- ClinicalTrials.gov ID
- NCT00576641
- Acronym / sponsor ID
- 6657
- Conditions
- Brain Stem Glioma, Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Dec 2007 (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 purpose of the Dendritic Cell Immunotherapy study for patients with glioblastoma and/or brainstem glioma is to determine whether in patients with malignant brain tumors, dendritic cells injected peripherally can reactivate the immune system against the brain tumor.
Detailed description
Patients will have their white blood cells removed and grown in culture under conditions to make dendritic cells. Dendritic cells are a small group of cells that belong to the white blood cell population. These cells are responsible for letting the immune system know that something foreign, like bacteria or a tumor, is in the body. Dendritic cells help the body ward off disease by alerting the immune system. In previous clinical trials, brain tumor cells called astrocytoma tumor cells and glioblastoma tumor cells were taken from the tumor that was removed during surgery. The brain tumor cells were then placed into a solution in the laboratory that made them grow. Certain parts of the brain tumor's proteins (peptides) were removed from the growing tumor cells and mixed together with the dendritic cells in the blood taken from a vein. This combination of dendritic cells and brain tumor peptides were injected into the patient's skin, like a vaccination. This process is similar to that used in vaccinations. The patients were given three and four injections of dendritic cells mixed with the tumor peptides over the course of a twenty-eight day period.
In this study, the proteins that are manufactured and known to be associated with brain cancers will be mixed with the dendritic cells obtained during leukopheresis (a procedure in which the dendritic cells are separated from the patients' blood). They will then undergo three vaccinations along with follow up clinic visits (which include evaluations and laboratory tests) to check their status.
The investigators learned that it was possible to generate an immune response in a subset of patients with malignant glioma. In addition, these cells were able to reach the brain and kill brain tumor cells. The survival of patients in this study was prolonged when compared to historical controls. Based on clinical data in subjects with brain tumors, the investigators believe that peripheral injection of dendritic cells will generate a more potent immune response for patients with brain stem gliomas and/or glioblastomas. The investigators hope to determine whether this therapy will translate into a longer survival and better quality of life in these patients in whom survival is measured in months. Through this study the investigators hope to learn more about the role of the body's immune response against cancer and about the use of dendritic cells for immunotherapy. This information may prove useful in the therapy of patients with glioblastoma and/or brainstem gliomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: autologous dendritic cells |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must be HLA -A1 or HLA - A2 positive
- Both male and female of child bearing age must use medically accepted form of birth control
- Confirmed brain stem glioma and glioblastoma with MRI
- Presence of at least one of the antigens by immunohistochemistry
- Karnofsky performance of at least 60%
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| autologous dendritic cells | Biological | Vaccine |
Primary outcome
Evaluate safety/toxicity of Dendritic cell vaccine, Monitor survival and time to progression and monitor the cellular immune responses.
Time frame: 1 year
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 30 Oct 2014.
- Derived from this study: PubMed 24893855Jouanneau E, Black KL, Veiga L, Cordner R, Goverdhana S, Zhai Y, Zhang XX, Panwar A, Mardiros A, Wang H, Gragg A, Zandian M, Irvin DK, Wheeler CJ. Intrinsically de-sialylated CD103(+) CD8 T cells mediate beneficial anti-glioma immune responses. Cancer Immunol Immunother. 2014 Sep;63(9):911-24. doi: 10.1007/s00262-014-1559-2. Epub 2014 Jun 4.
Related trials for Brain Stem Glioma
RecruitingPhase 1
PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
Neuroblastoma, Diffuse Intrinsic Pontine Glioma
Active, not recruitingPhase 2
Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
Glioblastoma, Medulloblastoma
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
RecruitingPhase 2
A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma
Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
Not yet recruitingPhase 1
Immune Modulatory DC Vaccine Against Brain Tumor
Diffuse Intrinsic Pontine Glioma or 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.
Surasak Phuphanich, M.D. principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous dendritic cells in people with Brain Stem Glioma and Glioblastoma, run by Cedars-Sinai Medical Center at 1 site in United States.
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 10 inclusion and 0 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 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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?
Evaluate safety/toxicity of Dendritic cell vaccine, Monitor survival and time to progression and monitor the cellular immune responses. (time frame: 1 year). 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 NCT00576641, 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 30 Oct 2014.