A Phase I/II Evaluation of Cytokine Induced Killer Cells Stimulated by DC(DCIK) Immunotherapy in Patients With Renal Cell Carcinoma
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
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
1. Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the
2. Presence of acute infection.
3. Inability to obtain informed consent because of psychiatric or complicating medical
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.