NCT01240005

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 15, 2010

Status Verified

November 1, 2010

Enrollment Period

1.9 years

First QC Date

November 12, 2010

Last Update Submit

November 12, 2010

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • overall survival

    1 year

Secondary Outcomes (1)

  • Objective tumor response, Time to recurrence, Progression-free, Cellular immunity.

    1 year

Study Arms (1)

DCIK

EXPERIMENTAL
Biological: DCIK

Interventions

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.

DCIK

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • Pregnancy or breast-feeding.
  • Positive for hepatitis B, C, HIV, syphilis.
  • Patients unwilling to perform a save method of birth control.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem cell cencter of the affiliated hospital of medical colledge,qingdao university

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Yongheng An

    The affilited hospital of medical college,Qingdao university

    STUDY CHAIR

Central Study Contacts

Yongheng An

CONTACT

+86-532-82911676anyongheng@126.com

Xuefeng Zhang

CONTACT

+86-13789861225xuefengzhang15@126.com,qdstemcell@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2010

First Posted

November 15, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

September 1, 2013

Last Updated

November 15, 2010

Record last verified: 2010-11

Locations

CN(1)