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A Phase I/II Evaluation of Cytokine Induced Killer Cells Stimulated by DC(DCIK) Immunotherapy in Patients With Renal Cell Carcinoma


Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Both
Renal Cell Carcinoma

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Trial Information

A Phase I/II Evaluation of Cytokine Induced Killer Cells Stimulated by DC(DCIK) Immunotherapy in Patients With Renal Cell Carcinoma


Inclusion Criteria:



1. Female or male, adult patients of 18 to 75 years of age at time of diagnosis that
qualify for standard treatment including surgery.

2. Histologically confirmed diagnosis of renal cell carcinoma.

3. Newly diagnosed or recurrent disease.

4. Karnofsky performance status 60-100.

5. Life expectancy ≥ 12 weeks.

6. Written informed consent of patient and/or legal guardian.

7. Must be off steroid at least two weeks prior to vaccination.

8. Hematologic and metabolic panel results will be within the parameters of the
protocol.

9. Normal renal function in the kidney.

10. Adequate function of liver,lung and heart.

11. Negative pregnancy test

12. Fertile patients must use effective contraception

13. Serologically negative for HIV,HBV,HCV.

14. Syphilis serology negative

15. Patient must have no prior sensitivity to the components of the dendritic cell
vaccine.

Exclusion Criteria:

1. Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the
study.

2. Presence of acute infection.

3. Inability to obtain informed consent because of psychiatric or complicating medical
problems.

4. Patients with other significant illness including severe allergy, asthma, angina
pectoris or congestive heart failure.

5. Subjects with organ allografts.

6. Known history of autoimmune disorder.

7. Pregnancy or breast-feeding.

8. Positive for hepatitis B, C, HIV, syphilis.

9. Patients unwilling to perform a save method of birth control.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Yongheng An

Investigator Role:

Study Chair

Investigator Affiliation:

The affilited hospital of medical college,Qingdao university

Authority:

China: Ethics Committee

Study ID:

DCCIK002

NCT ID:

NCT01240005

Start Date:

January 2011

Completion Date:

September 2013

Related Keywords:

  • Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

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