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

Primary Purpose

Malignant Glioma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Biological: DC activated CIK combined with DC

About this trial

This is an interventional treatment trial for Malignant Glioma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Stem cell cencter of the affiliated hospital of medical colledge,qingdao university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DC-DCIK

Arm Description

Outcomes

Primary Outcome Measures

To assess the survival of malignant glioma

Secondary Outcome Measures

To assess the immune response of patients, to assess progression free survival and to evaluate quality of life.

Full Information

NCT ID

NCT01235845

First Posted

November 5, 2010

Last Updated

December 2, 2010

Sponsor

Qingdao University

1. Study Identification

Unique Protocol Identification Number

NCT01235845

Brief Title

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

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Qingdao University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Glioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DC-DCIK

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Biological: DC activated CIK combined with DC

Intervention Description

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.

Primary Outcome Measure Information:

Title

To assess the survival of malignant glioma

Time Frame

1 year

Secondary Outcome Measure Information:

Title

To assess the immune response of patients, to assess progression free survival and to evaluate quality of life.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

xuefeng zhang

Phone

+86-532-82911676

xuefengzhang15@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

yingbin jiao

hnjyb123@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weicheng Yao

Organizational Affiliation

2010 year

Official's Role

Study Chair

Facility Information:

Facility Name

Stem cell cencter of the affiliated hospital of medical colledge,qingdao university

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

xuefeng zhang

Phone

+86-532-82911676

xuefengzhang15@126.com

First Name & Middle Initial & Last Name & Degree

yingbin jiao

hnjyb123@163.com

First Name & Middle Initial & Last Name & Degree

Weicheng Yao

12. IPD Sharing Statement

Learn more about this trial

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

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