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Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas (NCT02771301)

Beijing Tiantan Hospital
This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma with IDH1R132H mutation.
  • Biological: dendritic cells
    Concurrent of radiotherapy and chemotherapy plus 12 cycles of dendritic cells and cytotoxic lymphocytes treatment
    Ages eligible for Study
    18 Years to 70 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • 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 ;
    • 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:
    • 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
    • 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.
    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.

    2 locations

    China (2)
    • Beijing Tiantan Hospital
      recruiting
      Beijing, Beijing, China, 100000
    • Hebei Yanda Hospital
      recruiting
      Sanhe, Hebei, China, 065200
    Status:
    unknown
    Type:
    Interventional
    Phase:
    -
    Start:
    31 January, 2016
    Updated:
    10 May, 2016
    Participants:
    30
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