Malignant GliomaPhase 1/2NCT01235845
Dendritic Cell (DC) Activated Cytokine-induced Killer Cell (DCIK) Combined With DC Treatment for Glioma
A Phase 1/2 study testing Biological: DC activated CIK combined with DC in people with Malignant Glioma, run by Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- Biological: DC activated CIK combined with DC
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Sep 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 19Show fewer
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
yingbin jiao contact
China1 site
Stem cell cencter of the affiliated hospital of medical colledge,qingdao university
Qingdao, Shandong, 266000
xuefeng zhang, +86-532-82911676, xuefengzhang15@126.com
yingbin jiao, hnjyb123@163.com
About this study
Official title: A Phase I/II Clinical Trial Evaluating DC Activated Cytokine-induced Killer Cell(DCIK) Combined With DC Treatment for Glioma
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.
Read more
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.
- Conditions
- Malignant Glioma
- Being tested
- Biological: DC activated CIK combined with DC
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: DC activated CIK combined with DCBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| DC-DCIK | Experimental | Not described Receives: Biological: Biological: DC activated CIK combined with DC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the survival of malignant glioma
Measured: 1 year
Secondary outcomes (1)
To assess the immune response of patients, to assess progression free survival and to evaluate quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Investigators
- Weicheng Yao, Study chair, 2010 year
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235845
- Sponsor's protocol ID
- DCCIK001
- Status last verified
- Nov 2010
- First submitted
- 5 Nov 2010
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial Evaluating DC Activated Cytokine-induced Killer Cell(DCIK) Combined With DC Treatment for Glioma
- ClinicalTrials.gov ID
- NCT01235845
- Acronym / sponsor ID
- DCCIK001
- Conditions
- Malignant Glioma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC-DCIK | Experimental | Biological: Biological: DC activated CIK combined with DC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological: DC activated CIK combined with DCDendritic 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. | Biological | DC-DCIK |
Primary outcome
To assess the survival of malignant glioma
Time frame: 1 year
1 secondary outcome
To assess the immune response of patients, to assess progression free survival and to evaluate quality of life.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
Related trials for Malignant Glioma
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
RecruitingEarly Phase 1
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Diffuse Glioma, Malignant Glioma
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
Active, not recruitingPhase 1/2
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Malignant Glioma
RecruitingPhase 2
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
High Grade Glioma, CNS Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yingbin jiao contact
Weicheng Yao study chair
2010 year
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Biological: DC activated CIK combined with DC in people with Malignant Glioma, run by Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xuefeng zhang (+86-532-82911676, xuefengzhang15@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the survival of malignant glioma (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2010.