Renal NeoplasmaPhase 2NCT02487550
DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating
A Phase 2 study testing DC-CIK and IL-2/IFN-α in people with Renal Neoplasma, run by The First People's Hospital of Changzhou.
Trial summary
The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regimen. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Neoplasma
- What is being tested?
- DC-CIK and IL-2/IFN-α
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven renal cell carcinoma
- Age: > 18
- WHO- ECOG Performance Status 0-1
- At least one measurable tumor lesions according to the RECIST criteria.
- Life expectancy more than 3 months
- Written informed consent
Who cannot join
- Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
- Patients with metastatic disease in the central nervous system (CNS).
- Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
- Patients with acute or chronic infection including HIV.
- Patients who are pregnant or nursing.
- Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
- Patients who receive corticosteroids or other immunosuppressive agents.
- Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
About this study
The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regimen.
Read the detailed description
The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regime.
Primary
- Determine the clinical responses(objective response, progression-free survival, and overall survival) in patients with renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with Cytokine-Induced Killer Cell (CIK).
Secondary
- Determine cellular immune response response in terms of immuknow assay, and correlate immune response with objective clinical response in patients treated with this regimen.
- Determine safety of multiple administrations of this regimens in these patients.
- Conditions
- Renal Neoplasma
- Being tested
- DC-CIK, IL-2/IFN-α
- Keywords
- Renal neoplasma, CIK cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-CIKBiological
Patients with renal cell carcinoma will receive autologous dendritic cells loaded with autologous tumor lysate (dendritic cell vaccine) by venous infusion of CIK cells.
IL-2/IFN-αBiological
Patients with renal cell carcinoma will receive IL-2/IFN-α by venous infusion.
| Study group | Role | What they receive |
|---|---|---|
| DC-CIK | Experimental | Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells. Receives: Biological: DC-CIK |
| IL-2/IFN-α | Other | Patients receive treatment of IL-2 or IFN-α. Receives: Biological: IL-2/IFN-α |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free time
Measured: 3 months
Overall-survival time
Measured: 3 months
Secondary outcomes (1)
Objective tumor response
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2028 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal NeoplasmaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaodong li, The First People's Hospital of Changzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487550
- Sponsor's protocol ID
- CIKRC001
- Status last verified
- Jun 2015
- First submitted
- 24 Jun 2015
- Last updated
- 1 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating
- ClinicalTrials.gov ID
- NCT02487550
- Acronym / sponsor ID
- CIKRC001
- Conditions
- Renal Neoplasma
- Keywords
- Renal neoplasma, CIK cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 1 Jul 2015 (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.
The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regimen.
Detailed description
The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with tumor lysate in combination with Cytokine-Induced Killer Cell (CIK) can induce a measurable immune response in patients with renal cell carcinoma, and to evaluate the clinical effect of the regime.
Primary
- Determine the clinical responses(objective response, progression-free survival, and overall survival) in patients with renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) in combination with Cytokine-Induced Killer Cell (CIK).
Secondary
- Determine cellular immune response response in terms of immuknow assay, and correlate immune response with objective clinical response in patients treated with this regimen.
- Determine safety of multiple administrations of this regimens in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DC-CIK | Experimental | Biological: DC-CIKPatients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells. |
| IL-2/IFN-α | Other | Biological: IL-2/IFN-αPatients receive treatment of IL-2 or IFN-α. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically proven renal cell carcinoma
- Age: > 18
- WHO- ECOG Performance Status 0-1
- At least one measurable tumor lesions according to the RECIST criteria.
- Life expectancy more than 3 months
Key exclusion criteria (8 listed)
- Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
- Patients with metastatic disease in the central nervous system (CNS).
- Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
- Patients with acute or chronic infection including HIV.
- Patients who are pregnant or nursing.
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 |
|---|---|---|
| DC-CIKPatients with renal cell carcinoma will receive autologous dendritic cells loaded with autologous tumor lysate (dendritic cell vaccine) by venous infusion of CIK cells. | Biological | DC-CIK |
| IL-2/IFN-αPatients with renal cell carcinoma will receive IL-2/IFN-α by venous infusion. | Biological | IL-2/IFN-α |
Primary outcome
Progression-free time
Time frame: 3 months
Overall-survival time
Time frame: 3 months
1 secondary outcome
Objective tumor response
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DC-CIK and IL-2/IFN-α in people with Renal Neoplasma, run by The First People's Hospital of Changzhou.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free time (time frame: 3 months). The study lists 2 primary outcomes in all. 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 1 Jul 2015.