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

Qingdao University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Malignant Glioma

Treatments

Biological: Biological: DC activated CIK combined with DC

Study type

Interventional

Funder types

Other

Identifiers

NCT01235845

DCCIK001

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

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