Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas

Glioma Clinical Trial

Official title:

Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02771301
• Other study ID #: IDH1
• Status: Recruiting
• Phase: N/A
• First received: May 10, 2016
• Last updated: May 11, 2016
• Start date: February 2016
• Est. completion date: January 2019

Study information

• Verified date: May 2016
• Source: Hebei Yanda Hospital
• Contact: Nan Ji, PhD
• Phone: 0086 13910713896
• Email: idh1yd[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This trial is aimed at evaluating the safety and efficacy of IDH1R132H-DC vaccine in glioma with IDH1R132H mutation.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma

Intervention

Biological:
• dendritic cells
Concurrent of radiotherapy and chemotherapy plus 12 cycles of dendritic cells and cytotoxic lymphocytes treatment

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing
China	Hebei Yanda Hospital	Sanhe	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Hebei Yanda Hospital	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 year	Yes
Secondary	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.	2 year	No