Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2016-02-29
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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dendritic cell
Patients will receive autolgous IDH1R132H dendritic cells and cytotoxic lymphocytes treatment.
dendritic cells
Concurrent of radiotherapy and chemotherapy plus 12 cycles of dendritic cells and cytotoxic lymphocytes treatment
Interventions
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dendritic cells
Concurrent of radiotherapy and chemotherapy plus 12 cycles of dendritic cells and cytotoxic lymphocytes treatment
Eligibility Criteria
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Inclusion Criteria
* 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 ;
* 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.
Exclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Hebei Yanda Hospital
OTHER
Responsible Party
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Nan Ji
Professor of Neurosurgery
Principal Investigators
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Nan Ji, PhD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Hebei Yanda Hospital
Sanhe, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IDH1
Identifier Type: -
Identifier Source: org_study_id
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