GlioblastomaPhase 2NCT00576537
Tumor Lysate Pulsed Dendritic Cell Immunotherapy for Patients With Brain Tumors
A Phase 2 study testing Dendritic Cell Immunotherapy in people with Glioblastoma, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This research is being determine whether vaccinations with your own immune cells called " dendritic cells " can activate your immune system to fight your brain tumor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Dendritic Cell Immunotherapy
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Oct 2011
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- No age or gender limit, though minimal weight limitations for apheresis is about 15 - 20 Kg.
- Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female.
- patients with atypical malignant brain tumor will be eligible.
- Patients must have a Karnofsky performance score of at least 60%
- patients may be maintained on glucocorticoid therapy at the lowest possible dose.
- Baseline hematologic studies and chemistry profiles must meet the criteria.
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- Tumor specimen of adequate size to yield protein concentration in sufficient quantity.
- Tumor-lysate peptide must be generated in sufficient quantity to pulse the APC's for vaccination.
- Patient must have no prior sensitivity to the components of the dendritic cell vaccine.
- Patient must agree to consider an autopsy in the event of death in an attempt to learn more concerning the nature of this treatment and tumor biology.
- Patient must be capable of signing IRB approved Research Consent and Release of medical Records form.
Who cannot join
- Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.
- The presence of an acute infection requiring active treatment will be criteria for delay or exclusion.
- Patients with a known history of an autoimmune disorder.
- Inability to give informed consent.
- Pregnancy.
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: Phase ll Trial of Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Patients With Atypical or Malignant, Primary or Metastatic Brain Tumors of the Central Nervous System
This research is being determine whether vaccinations with your own immune cells called " dendritic cells " can activate your immune system to fight your brain tumor.
Read the detailed description
To become eligible for therapy the following criteria must be fulfilled:
- No age or gender limit
- Patients with atypical malignant brain tumors.
- Must have a Karnofsky performance of at least 60%
- Hematologic studies and chemistry profiles will be within the parameters of the protocol
- Tumor specimen of adequate size to yield protein concentration, tumor lysate peptide must be generated in sufficient quantity and patient must have no prior sensitivity to the components of the dendritic cell vaccine.
- Patients are excluded if they have systemic disease, presence of acute infection, known history of autoimmune disorder and pregnancy.
- Conditions
- Glioblastoma
- Being tested
- Dendritic Cell Immunotherapy
- Keywords
- New/Recurrent Glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic Cell ImmunotherapyBiological
Also called Dendritic Cell vaccine
Patients will receive four vaccines.
| Study group | Role | What they receive |
|---|---|---|
| Dendritic Cell Immunotherapy | Experimental | Patients who consent to participate in the study and receive the Dendritic Cell vaccine manufactured from their own tumor cells. Receives: Biological: Dendritic Cell Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells
Cytotoxic T lymphocyte (CTL) precursor frequency
Measured: One 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 startMar 2001
- Primary completionOct 2011
- Study completionOct 2011
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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Yu, Cedars-Sinai Medical Center
- Investigators
- John Yu, M.D., Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576537
- Sponsor's protocol ID
- 3368
- Status last verified
- Apr 2019
- First submitted
- 18 Dec 2007
- Last updated
- 3 May 2019
- 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 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase ll Trial of Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Patients With Atypical or Malignant, Primary or Metastatic Brain Tumors of the Central Nervous System
- ClinicalTrials.gov ID
- NCT00576537
- Acronym / sponsor ID
- 3368
- Conditions
- Glioblastoma
- Keywords
- New/Recurrent Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Mar 2001
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (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.
This research is being determine whether vaccinations with your own immune cells called " dendritic cells " can activate your immune system to fight your brain tumor.
Detailed description
To become eligible for therapy the following criteria must be fulfilled:
- No age or gender limit
- Patients with atypical malignant brain tumors.
- Must have a Karnofsky performance of at least 60%
- Hematologic studies and chemistry profiles will be within the parameters of the protocol
- Tumor specimen of adequate size to yield protein concentration, tumor lysate peptide must be generated in sufficient quantity and patient must have no prior sensitivity to the components of the dendritic cell vaccine.
- Patients are excluded if they have systemic disease, presence of acute infection, known history of autoimmune disorder and pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dendritic Cell Immunotherapy | Experimental | Biological: Dendritic Cell ImmunotherapyPatients who consent to participate in the study and receive the Dendritic Cell vaccine manufactured from their own tumor cells. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- No age or gender limit, though minimal weight limitations for apheresis is about 15 - 20 Kg.
- Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female.
- patients with atypical malignant brain tumor will be eligible.
- Patients must have a Karnofsky performance score of at least 60%
- patients may be maintained on glucocorticoid therapy at the lowest possible dose.
Key exclusion criteria (5 listed)
- Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.
- The presence of an acute infection requiring active treatment will be criteria for delay or exclusion.
- Patients with a known history of an autoimmune disorder.
- Inability to give informed consent.
- Pregnancy.
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 ImmunotherapyAlso: Dendritic Cell vaccinePatients will receive four vaccines. | Biological | Dendritic Cell Immunotherapy |
Primary outcome
Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells
Time frame: One year
Cytotoxic T lymphocyte (CTL) precursor frequency
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 3 May 2019.
- 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.
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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.
John Yu, 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 2 study testing Dendritic Cell Immunotherapy in people with 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 11 inclusion and 5 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 3 May 2019. 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 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?
Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells (time frame: One 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 NCT00576537, 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 3 May 2019.