DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma

NCT ID: NCT01924156

Last Updated: 2016-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-12-31

Brief Summary

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The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with renal cell carcinoma. Experimental recombinant adenovirus-transfected DC, which engineered to express MUC1 and Survivin are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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adenovirus-transfected DC + CIK

adenovirus-transfected autologous DC vaccine plus CIK cells

Group Type EXPERIMENTAL

adenovirus-transfected DC + CIK

Intervention Type BIOLOGICAL

adenovirus-transfected DC vaccine plus CIK cells

Interventions

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adenovirus-transfected DC + CIK

adenovirus-transfected DC vaccine plus CIK cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years at time of consent
* Histopathologically confirmed diagnosis of renal cell carcinoma
* Received standardized treatment of renal cell carcinoma
* Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
* KPS (Karnofsky performance scale) \>60
* Patient's written informed consent
* Predicted survival \>3 months
* No severe viral or bacterial infections

Exclusion Criteria

* Receiving chemotherapy, radiotherapy or other therapy
* Patients with other malignancies and infectious diseases
* Pregnant and breast-feeding patient
* Currently participating in another clinical trial
* Unfit for participating in this clinical trial in investigators' opinions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hu Chen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital to Academy of Military Medical Sciences

Locations

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Department of Hematopoietic Stem Cell Transplantation

Beijing, , China

Site Status

Countries

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China

References

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Wang D, Zhang B, Gao H, Ding G, Wu Q, Zhang J, Liao L, Chen H. Clinical research of genetically modified dendritic cells in combination with cytokine-induced killer cell treatment in advanced renal cancer. BMC Cancer. 2014 Apr 10;14:251. doi: 10.1186/1471-2407-14-251.

Reference Type DERIVED
PMID: 24720900 (View on PubMed)

Other Identifiers

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307-CTC-DC/CIK-RCC

Identifier Type: -

Identifier Source: org_study_id

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