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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC-DCIK | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological: DC activated CIK combined with DC | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the survival of malignant glioma | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the immune response of patients, to assess progression free survival and to evaluate quality of life. | 1 year |
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Inclusion Criteria:
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.
Histologically confirmed diagnosis of 1 of the following malignant gliomas:
Anaplastic astrocytoma Glioblastoma multiforme Oligodendroglioma Oligoastrocytoma
Newly diagnosed or recurrent disease
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.
After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV) will need to be established.
Supratentorial tumour localisation.
Karnofsky performance status 60-100%
Life expectancy ≥ 12 weeks
Written informed consent of patient and/or legal guardian.
Must be off of steroid at least two weeks prior to vaccination
Hematologic and metabolic panel results will be within the parameters of the protocol.
Negative pregnancy test
Fertile patients must use effective contraception
Hepatitis B negative
Hepatitis C negative
HIV negative
Syphilis serology negative
Patient must have no prior sensitivity to the components of the dendritic cell vaccine.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xuefeng zhang | Contact | +86-532-82911676 | xuefengzhang15@126.com | |
| yingbin jiao | Contact | hnjyb123@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weicheng Yao | 2010 year | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stem cell cencter of the affiliated hospital of medical colledge,qingdao university | Qingdao | Shandong | 266000 | China |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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|
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |