Cytokine Induced Killer Cells Stimulated by DC Immunotherapy for Renal Cell Carcinoma

Qingdao University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Renal Cell Carcinoma

Treatments: Biological: DCIK

Study type: Interventional

Funder types: Other

Identifiers

NCT01240005

DCCIK002

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

DCIK

Experimental group

Treatment:

Biological: DCIK