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

This study is not yet open for participant recruitment.
Verified November 2010 by Qingdao University
Sponsor:
Information provided by:
Qingdao University
ClinicalTrials.gov Identifier:
NCT01235845
First received: November 5, 2010
Last updated: December 2, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention Phase
Malignant Glioma
 Biological: Biological: DC activated CIK combined with DC
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Qingdao University:

Primary Outcome Measures:
  • To assess the survival of malignant glioma [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the immune response of patients, to assess progression free survival and to evaluate quality of life. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235845

Contacts
Contact: xuefeng zhang +86-532-82911676 xuefengzhang15@126.com
Contact: yingbin jiao hnjyb123@163.com

Locations
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     xuefengzhang15@126.com    
Contact: yingbin jiao         hnjyb123@163.com    
Principal Investigator: Weicheng Yao            
Sponsors and Collaborators
Qingdao University
Investigators
Study Chair: Weicheng Yao 2010 year
  More Information

No publications provided

Responsible Party: Yao Weicheng, Dou Yihe, Gao Hong, Jiao Yingbin, Zhang Xuefeng, Stemcell center of the affiliated hospital of medical colledge,Qingdao university
ClinicalTrials.gov Identifier: NCT01235845     History of Changes
Other Study ID Numbers: DCCIK001
Study First Received: November 5, 2010
Last Updated: December 2, 2010
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on May 21, 2013