GliomaNCT02771301
Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas
A study testing dendritic cells in people with Glioma, run by Hebei Yanda Hospital at 2 sites in China.
Trial summary
This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma with IDH1R132H mutation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma
- What is being tested?
- dendritic cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- Feb 2016to Jan 2019
- Phase
- Interventional
- 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
- The patient signed "informed consent" voluntarily;
- The age of patient is between 18 and 70 years;
- The tumor can be resected and tumor resection rate ≥80%;
- IDH1R132H mutation can be confirmed by immunohistochemistry or real-time quantitative PCR;
- Peripheral blood lymphocytes absolute value is not less than 0.8 × 106;
- KPS score ≥70 ;
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- The patient has normal bone marrow reserve and normal liver and kidney function ( The bone marrow, liver and kidney function must be confirmed by Laboratory examination to meet the requirements of participating in the study within 3 days before the first acceptance of IDH1R132H-DC tumor vaccine therapy): Medium neutrophil absolute value ≥1,500 / mm3; hemoglobin> 10g / dL; platelet count> 100,000 / mm3; total bilirubin <1.5 × ULN; alanine aminotransferase / aspartate aminotransferase <2.5 × ULN; serum creatinine <1.5 × ULN;
- Normal heart function ;
- Better follow-up and compliance;
- For women of childbearing age (15 to 49 years)，pregnancy test must be negative 7 days before starting this study. Male and female patients of childbearing potential must agree to use effective contraceptive measures to ensure that during the study period and three months after cessation of treatment will not be pregnant.
Who cannot join
- The patient did not sign "informed consent" or signed unvoluntarily.
- Non-glioma patients
- Drugs for brain or antibody therapy had been used 4 weeks before the start of this study
- Active infection
- Human immunodeficiency virus (HIV) positive
- Hepatitis C or hepatitis B infective
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- Pregnancy or breast-feeding women
- Patients did not agree to use effective contraception during treatment and the following 3 months.
- Patients also participated in other clinical studies.
- The subjects researchers believe are not suitable for participation or completion of the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100000
Nan Ji, MD, +86 13910713896, idh1yd@126.com
Nan Ji, MD
- Recruiting
Hebei Yanda Hospital
Sanhe, Hebei, 065200
Nan Ji, MD, +86 13910713896, idh1yd@126.com
Nan Ji, MD
About this study
This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma with IDH1R132H mutation.
Read the detailed description
Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production. All patients will receive mature dendritic cells for a total of 12 vaccine doses.The DC vaccine will be given subcutaneously every four weeks. Peripheral blood will be taken two weeks after injection each time to monitor the immune response.
- Conditions
- Glioma
- Being tested
- dendritic cells
- Keywords
- IDH1R132H Dendritic cell glioma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dendritic cellsBiological
Concurrent of radiotherapy and chemotherapy plus 12 cycles of dendritic cells and cytotoxic lymphocytes treatment
| Study group | Role | What they receive |
|---|---|---|
| dendritic cell | Other | Patients will receive autolgous IDH1R132H dendritic cells and cytotoxic lymphocytes treatment. Receives: Biological: dendritic cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy of IDH1R132H dendritic cell vaccine as measured by adverse events
2 years progress free survival and overall suvival as measured by RECIST criteria 4.0
Measured: 2 year
Secondary outcomes (1)
Antigen specific cell responses before and after vaccination
Immunological response based on measuring increased numbers of IDH1R132H specific T cells and levels of anti-IDH1R132H antibody.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Yanda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Principal investigator, Nan Ji, Beijing Tiantan Hospital
- Investigators
- Nan Ji, PhD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771301
- Sponsor's protocol ID
- IDH1
- Status last verified
- May 2016
- First submitted
- 10 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas
- ClinicalTrials.gov ID
- NCT02771301
- Acronym / sponsor ID
- IDH1
- Conditions
- Glioma
- Keywords
- IDH1R132H Dendritic cell glioma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hebei Yanda HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- Feb 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 13 May 2016 (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 trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma with IDH1R132H mutation.
Detailed description
Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production. All patients will receive mature dendritic cells for a total of 12 vaccine doses.The DC vaccine will be given subcutaneously every four weeks. Peripheral blood will be taken two weeks after injection each time to monitor the immune response.
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 | Other | Biological: dendritic cellsPatients will receive autolgous IDH1R132H dendritic cells and cytotoxic lymphocytes treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient signed "informed consent" voluntarily;
- The age of patient is between 18 and 70 years;
- The tumor can be resected and tumor resection rate ≥80%;
- IDH1R132H mutation can be confirmed by immunohistochemistry or real-time quantitative PCR;
- Peripheral blood lymphocytes absolute value is not less than 0.8 × 106;
Key exclusion criteria (10 listed)
- The patient did not sign "informed consent" or signed unvoluntarily.
- Non-glioma patients
- Drugs for brain or antibody therapy had been used 4 weeks before the start of this study
- Active infection
- Human immunodeficiency virus (HIV) positive
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 cellsConcurrent of radiotherapy and chemotherapy plus 12 cycles of dendritic cells and cytotoxic lymphocytes treatment | Biological | dendritic cell |
Primary outcome
Safety and Efficacy of IDH1R132H dendritic cell vaccine as measured by adverse events
Time frame: 2 year
2 years progress free survival and overall suvival as measured by RECIST criteria 4.0
1 secondary outcome
Antigen specific cell responses before and after vaccination
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Nan Ji, PhD principal investigator
Beijing Tiantan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dendritic cells in people with Glioma, run by Hebei Yanda Hospital at 2 sites in China.
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 10 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: status not confirmed, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan Ji, PhD (0086 13910713896, idh1yd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy of IDH1R132H dendritic cell vaccine as measured by adverse events (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2016.