Clinical trial NCT01235845: Dendritic Cell (DC) Activated Cytokine-induced Killer Cell (DCIK) Combined With DC Treatment for Glioma
Official title: A Phase I/II Clinical Trial Evaluating DC Activated Cytokine-induced Killer Cell(DCIK) Combined With DC Treatment for Glioma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Malignant Glioma
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2010-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To assess the survival of malignant glioma
timeFrame: 1 year
Secondary outcomes:
measure: To assess the immune response of patients, to assess progression free survival and to evaluate quality of life.
timeFrame: 1 year
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Stem cell cencter of the affiliated hospital of medical colledge,qingdao university
state: Shandong
Study officials:
affiliation: 2010 year
name: Weicheng Yao
role: STUDY_CHAIR
References: