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

Phase 1

• Conditions: Malignant Glioma

• Registration Number: NCT01235845
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-07
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03
• Study Start: 2011-01
• Primary Completion: 2012-12
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the survival of malignant glioma	1 year

Secondary Outcome Measures

Name	Time	Method
To assess the immune response of patients, to assess progression free survival and to evaluate quality of life.	1 year

Trial Locations

Locations (1)

Stem cell cencter of the affiliated hospital of medical colledge,qingdao university; 🇨🇳 Qingdao, Shandong, China