Dendritic Cell (DC) Activated Cytokine-induced Killer Cell (DCIK) Combined With DC Treatment for Glioma
A Phase I/II Clinical Trial Evaluating DC Activated Cytokine-induced Killer Cell(DCIK) Combined With DC Treatment for Glioma
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2010
CompletedFirst Posted
Study publicly available on registry
November 8, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedDecember 3, 2010
November 1, 2010
1.9 years
November 5, 2010
December 2, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the survival of malignant glioma
1 year
Secondary Outcomes (1)
To assess the immune response of patients, to assess progression free survival and to evaluate quality of life.
1 year
Study Arms (1)
DC-DCIK
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stem cell cencter of the affiliated hospital of medical colledge,qingdao university
Qingdao, Shandong, 266000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Weicheng Yao
2010 year
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 5, 2010
First Posted
November 8, 2010
Study Start
January 1, 2011
Primary Completion
December 1, 2012
Study Completion
September 1, 2013
Last Updated
December 3, 2010
Record last verified: 2010-11