Dendritic Cell (DC) Activated Cytokine-induced Killer Cell (DCIK) Combined With DC Treatment for Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Qingdao University

Brief Summary:

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DC-DCIK 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.

Primary Outcome Measures :
  1. To assess the survival of malignant glioma [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To assess the immune response of patients, to assess progression free survival and to evaluate quality of life. [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Female or male, adult patients of 18 to 70 years of age at time of diagnosis that qualify for standard treatment including surgery and radiotherapy.
  2. Histologically confirmed diagnosis of 1 of the following malignant gliomas:

    Anaplastic astrocytoma Glioblastoma multiforme Oligodendroglioma Oligoastrocytoma

  3. Newly diagnosed or recurrent disease
  4. Patients must have had surgical resection at UCLA for the collection of their tumor. Total, subtotal, or partial resection of more then 70% of tumor mass defined by MRI.
  5. After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV) will need to be established.
  6. Supratentorial tumour localisation.
  7. Karnofsky performance status 60-100%
  8. Life expectancy ≥ 12 weeks
  9. Written informed consent of patient and/or legal guardian.
  10. Must be off of steroid at least two weeks prior to vaccination
  11. Hematologic and metabolic panel results will be within the parameters of the protocol.
  12. Negative pregnancy test
  13. Fertile patients must use effective contraception
  14. Hepatitis B negative
  15. Hepatitis C negative
  16. HIV negative
  17. Syphilis serology negative
  18. Patient must have no prior sensitivity to the components of the dendritic cell vaccine.

Exclusion Criteria:

  1. Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the study,
  2. Presence of acute infection
  3. Inability to obtain informed consent because of psychiatric or complicating medical problems.
  4. Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator.
  5. Subjects with organ allografts.
  6. Contraindication to MRI
  7. Known history of autoimmune disorder
  8. Subjects who have an uncontrolled systemic malignancy that is not in remission.
  9. Pregnancy or breast-feeding.
  10. Positive for hepatitis B, C, HIV, syphilis
  11. Patients unwilling to perform a save method of birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01235845

Contact: xuefeng zhang +86-532-82911676
Contact: yingbin jiao

China, Shandong
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   
Contact: yingbin jiao   
Principal Investigator: Weicheng Yao         
Sponsors and Collaborators
Qingdao University
Study Chair: Weicheng Yao 2010 year

Responsible Party: Yao Weicheng, Dou Yihe, Gao Hong, Jiao Yingbin, Zhang Xuefeng, Stemcell center of the affiliated hospital of medical colledge,Qingdao university Identifier: NCT01235845     History of Changes
Other Study ID Numbers: DCCIK001
First Posted: November 8, 2010    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue