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Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas

Primary Purpose

Glioma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dendritic cells
Sponsored by
Hebei Yanda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring IDH1R132H Dendritic cell glioma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan HospitalRecruiting
  • Hebei Yanda HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

dendritic cell

Arm Description

Patients will receive autolgous IDH1R132H dendritic cells and cytotoxic lymphocytes treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
May 10, 2016
Last Updated
May 11, 2016
Sponsor
Hebei Yanda Hospital
Collaborators
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02771301
Brief Title
Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas
Official Title
Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Yanda Hospital
Collaborators
Beijing Tiantan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
IDH1R132H Dendritic cell glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dendritic cell
Arm Type
Other
Arm Description
Patients will receive autolgous IDH1R132H dendritic cells and cytotoxic lymphocytes treatment.
Intervention Type
Biological
Intervention Name(s)
dendritic cells
Intervention Description
Concurrent of radiotherapy and chemotherapy plus 12 cycles of dendritic cells and cytotoxic lymphocytes treatment
Primary Outcome Measure Information:
Title
Safety and Efficacy of IDH1R132H dendritic cell vaccine as measured by adverse events
Description
2 years progress free survival and overall suvival as measured by RECIST criteria 4.0
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Antigen specific cell responses before and after vaccination
Description
Immunological response based on measuring increased numbers of IDH1R132H specific T cells and levels of anti-IDH1R132H antibody.
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Ji, PhD
Phone
0086 13910713896
Email
idh1yd@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan Ji, PhD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Ji, MD
Phone
+86 13910713896
Email
idh1yd@126.com
First Name & Middle Initial & Last Name & Degree
Nan Ji, MD
First Name & Middle Initial & Last Name & Degree
Shuangxi Bai, MD
Facility Name
Hebei Yanda Hospital
City
Sanhe
State/Province
Hebei
ZIP/Postal Code
065200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Ji, MD
Phone
+86 13910713896
Email
idh1yd@126.com
First Name & Middle Initial & Last Name & Degree
Nan Ji, MD
First Name & Middle Initial & Last Name & Degree
Shuangxi Bai, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Safety and Efficacy of IDH1R132H-DC Vaccine in Gliomas

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