Dendritic Cell (DC) Activated Cytokine-induced Killer Cell (DCIK) Combined With DC Treatment for Glioma
|ClinicalTrials.gov Identifier: NCT01235845|
Recruitment Status : Unknown
Verified November 2010 by Qingdao University.
Recruitment status was: Not yet recruiting
First Posted : November 8, 2010
Last Update Posted : December 3, 2010
Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis carries with it a median survival of approximately 12 months, with 90 - 95% of patients surviving less than 2 years. The current standard treatment of surgical resection followed by radiation therapy and chemotherapy has not substantially prolonged survival.
Dendritic cells (DCs) are immune cells that form part of the mammalian immune system. Their main function is to process antigen material and present it on the surface to other cells of the immune system, thus functioning as antigen-presenting cells.In the present study, DCs were used for antigen presentation of glioma antigens to directly induce a cytotoxic T-cell response. Cytokine-induced killer (CIK)cells are shown to be a heterogeneous population, and the major population expresses both the T cell marker CD3 and the NK cell marker CD56, and is termed NKT cells, which has shown significant anti-tumor activity in both clinical trials and animal studies.
Furthermore, CIK cells are able to expand significantly when they are cultured with DCs, and the CIK cells activated by DCs stimulation (DCIKs)have a characteristic which cytotoxic activity enhanced and show increased anti-tumor activity.
This study aimed to evaluate the clinical efficacy of DCIK cells treatment combined with DCs following tumor resection and radiotherapy in patients with malignant glioma.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Biological: Biological: DC activated CIK combined with DC||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Clinical Trial Evaluating DC Activated Cytokine-induced Killer Cell(DCIK) Combined With DC Treatment for Glioma|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||September 2013|
Biological: Biological: DC activated CIK combined with DC
Dendritic cells pulsed With tumor lysate were injected back into the patient intradermally close to a lymph node, DC vaccinations will be given every week for a total of four vaccinations.
DC activated CIK combined with IL-2 were injected intratumorally via an Ommaya reservoir every week for a total of two vaccinations.
- To assess the survival of malignant glioma [ Time Frame: 1 year ]
- To assess the immune response of patients, to assess progression free survival and to evaluate quality of life. [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235845
|Contact: xuefeng firstname.lastname@example.org|
|Contact: yingbin email@example.com|
|Stem cell cencter of the affiliated hospital of medical colledge,qingdao university||Not yet recruiting|
|Qingdao, Shandong, China, 266000|
|Contact: xuefeng zhang +86-532-82911676 firstname.lastname@example.org|
|Contact: yingbin jiao email@example.com|
|Principal Investigator: Weicheng Yao|
|Study Chair:||Weicheng Yao||2010 year|