Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas

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

Study Overview

• Status: Unknown
• Conditions: Glioma
• Intervention / Treatment: Biological: dendritic cells

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nan Ji, PhD; Phone Number: 0086 13910713896; Email: idh1yd@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Nan Ji, MD; Phone Number: +86 13910713896; Email: idh1yd@126.com
      • Principal Investigator: Shuangxi Bai, MD
  • Hebei
    • Sanhe, Hebei, China, 065200
      • Recruiting
      • Hebei Yanda Hospital
      • Contact: Nan Ji, MD; Phone Number: +86 13910713896; Email: idh1yd@126.com
      • Principal Investigator: Shuangxi Bai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: dendritic cell; Patients will receive autolgous IDH1R132H dendritic cells and cytotoxic lymphocytes treatment.	Biological: dendritic cells; Concurrent of radiotherapy and chemotherapy plus 12 cycles of dendritic cells and cytotoxic lymphocytes treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hebei Yanda Hospital
• Collaborators: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Nan Ji, PhD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (ANTICIPATED): January 1, 2019
• Study Completion (ANTICIPATED): January 1, 2019

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (ESTIMATE): May 13, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: IDH1R132H Dendritic cell glioma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: IDH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED