Clinical trial NCT02771301: Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas
Official title: Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glioma
Keywords: IDH1R132H Dendritic cell glioma
Lead sponsor: Hebei Yanda Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
First posted: 2016-05-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and Efficacy of IDH1R132H dendritic cell vaccine as measured by adverse events
timeFrame: 2 year
Secondary outcomes:
measure: Antigen specific cell responses before and after vaccination
timeFrame: 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Sanhe
country: China
facility: Hebei Yanda Hospital
state: Hebei
Study officials:
affiliation: Beijing Tiantan Hospital
name: Nan Ji, PhD
role: PRINCIPAL_INVESTIGATOR
References: