NCT02771301

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

2.9 years

First QC Date

May 10, 2016

Last Update Submit

May 11, 2016

Conditions

Glioma

Keywords

IDH1R132H Dendritic cell glioma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Antigen specific cell responses before and after vaccination

    2 year

Study Arms (1)

dendritic cell

OTHER

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

Biological: dendritic cells

Interventions

dendritic cellsBIOLOGICAL

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

dendritic cell

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Hebei Yanda Hospital

Sanhe, Hebei, 065200, China

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Nan Ji, PhD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Ji, PhD

CONTACT

0086 13910713896idh1yd@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurosurgery

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 13, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

CN(2)