DC Vaccine Therapy Combined With Cytokine-Induced Killer... | NCT02487550

Studies
DC Vaccine Therapy Combined With Cytokine-Induced Killer Cell in Treating

NCT02487550

Sponsor

The First People's Hospital of Changzhou

Status

Not yet recruiting

Last Update Posted

Jul 1, 2015Estimated

Enrollment

1,200Estimated

Phase

Phase 2

Conditions

Renal Neoplasma

Interventions

DC-CIK
IL-2/IFN-α

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Jul 2028Estimated

Completion Date

Jul 2030Estimated

First Submitted Date

Jun 24, 2015

First Submission Date that Met QC Criteria

Jun 29, 2015

First Posted Date

Jul 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2015

Last Update Posted Date

Jul 1, 2015Estimated

Description Module

Brief 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.

Detailed Description

Primary

1. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DC-CIK	Experimental	Patients receive autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by endermic injection and infusion of CIK cells.	Biological: DC-CIK
IL-2/IFN-α	Other	Patients receive treatment of IL-2 or IFN-α.	Biological: IL-2/IFN-α

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DC-CIK	Biological	Patients with renal cell carcinoma will receive autologous dendritic cells loaded with autologous tumor lysate (dendritic cell vaccine) by venous infusion of CIK cells.

Measure	Description	Time Frame
Progression-free time		3 months
Overall-survival time		3 months

Measure	Description	Time Frame
Objective tumor response		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided