Renal Cell CarcinomaPhase 1/2NCT01240005
Cytokine Induced Killer Cells Stimulated by DC Immunotherapy for Renal Cell Carcinoma
A Phase 1/2 study testing DCIK in people with Renal Cell Carcinoma, run by Qingdao University at 1 site in China.
Trial summary
30% of renal cell carcinoma patients have metastases, mostly in lung, liver and bones at the time of diagnosis. Because of poor response to radiation therapy or chemotherapy, several studies have been initiated to find alternative therapeutic options. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- DCIK
- Type of treatment
- Injection or infusion
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male, adult patients of 18 to 75 years of age at time of diagnosis that qualify for standard treatment including surgery.
- Histologically confirmed diagnosis of renal cell carcinoma.
- Newly diagnosed or recurrent disease.
- Karnofsky performance status 60-100.
- Life expectancy ≥ 12 weeks.
- Written informed consent of patient and/or legal guardian.
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- Must be off steroid at least two weeks prior to vaccination.
- Hematologic and metabolic panel results will be within the parameters of the protocol.
- Normal renal function in the kidney.
- Adequate function of liver,lung and heart.
- Negative pregnancy test
- Fertile patients must use effective contraception
- Serologically negative for HIV,HBV,HCV.
- 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.
- Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
- Subjects with organ allografts.
- Known history of autoimmune disorder.
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- 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.
China1 site
Stem cell cencter of the affiliated hospital of medical colledge,qingdao university
Qingdao, Shandong, 266000
Xuefeng Zhang, +86-13789861225, xuefengzhang15@126.com,qdstemcell@126.com
Yongheng An, +86-532-82911676, anyongheng@126.com,lyj2001353@163.com
About this study
Official title: A Phase I/II Evaluation of Cytokine Induced Killer Cells Stimulated by DC(DCIK) Immunotherapy in Patients With Renal Cell Carcinoma
30% of renal cell carcinoma patients have metastases, mostly in lung, liver and bones at the time of diagnosis. Because of poor response to radiation therapy or chemotherapy, several studies have been initiated to find alternative therapeutic options.
Cytokine induced killer cells(CIK) are an unique population of cytotoxic T lymphocytes with a characteristic CD3+ CD56+ phenotype; they can be generated from cytokine cocktail-induced peripheral blood mononuclear cells (PBMC). CIK cells represent strong anti-tumor cytotoxicity in vitro and in vivo. Interestingly,the anti-tumor activity of CIK cells can be enhanced by incubation with dendritic cells (DC), which are the most potent antigen (Ag)-presenting cells.
The purpose of this study was to evaluate the clinical efficacy of DC-activated CIK cell treatment following regular therapy and the effects of this therapy on immune responses in patients with renal cell carcinoma after surgery.
- Conditions
- Renal Cell Carcinoma
- Being tested
- DCIK
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCIKBiological
Renal cell carcinoma patients were treated with three intravenous infusions of DC activated CIK cells at 1-day intervals. Clinical examinations of these patients were performed.
| Study group | Role | What they receive |
|---|---|---|
| DCIK | Experimental | Not described Receives: Biological: DCIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 1 year
Secondary outcomes (1)
Objective tumor response, Time to recurrence, Progression-free, Cellular immunity.
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 posted15 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 Renal Cell CarcinomaStudies 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
- Yongheng An, Study chair, The affilited hospital of medical college,Qingdao university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240005
- Sponsor's protocol ID
- DCCIK002
- Status last verified
- Nov 2010
- First submitted
- 12 Nov 2010
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Evaluation of Cytokine Induced Killer Cells Stimulated by DC(DCIK) Immunotherapy in Patients With Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01240005
- Acronym / sponsor ID
- DCCIK002
- Conditions
- Renal Cell Carcinoma
- 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
- 15 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.
30% of renal cell carcinoma patients have metastases, mostly in lung, liver and bones at the time of diagnosis. Because of poor response to radiation therapy or chemotherapy, several studies have been initiated to find alternative therapeutic options.
Cytokine induced killer cells(CIK) are an unique population of cytotoxic T lymphocytes with a characteristic CD3+ CD56+ phenotype; they can be generated from cytokine cocktail-induced peripheral blood mononuclear cells (PBMC). CIK cells represent strong anti-tumor cytotoxicity in vitro and in vivo. Interestingly,the anti-tumor activity of CIK cells can be enhanced by incubation with dendritic cells (DC), which are the most potent antigen (Ag)-presenting cells.
The purpose of this study was to evaluate the clinical efficacy of DC-activated CIK cell treatment following regular therapy and the effects of this therapy on immune responses in patients with renal cell carcinoma after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCIK | Experimental | Biological: DCIK |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female or male, adult patients of 18 to 75 years of age at time of diagnosis that qualify for standard treatment including surgery.
- Histologically confirmed diagnosis of renal cell carcinoma.
- Newly diagnosed or recurrent disease.
- Karnofsky performance status 60-100.
- Life expectancy ≥ 12 weeks.
Key exclusion criteria (9 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.
- Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
- 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 |
|---|---|---|
| DCIKRenal cell carcinoma patients were treated with three intravenous infusions of DC activated CIK cells at 1-day intervals. Clinical examinations of these patients were performed. | Biological | DCIK |
Primary outcome
overall survival
Time frame: 1 year
1 secondary outcome
Objective tumor response, Time to recurrence, Progression-free, Cellular immunity.
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 15 Nov 2010.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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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.
Yongheng An study chair
The affilited hospital of medical college,Qingdao university
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 DCIK in people with Renal Cell Carcinoma, 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 15 inclusion and 9 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 15 Nov 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 Yongheng An (+86-532-82911676, anyongheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (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 15 Nov 2010.