Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.

• Status: Terminated
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Renal cell carcinoma represents today 3% of the solid tumors of the adult. Their bad prognosis is due to the frequency of metastasis and the resistance to chemotherapy. Immunotherapy (interferon-α, interleukin-2) has shown some good results but an important toxicity. In our study, we evaluate the response to a new therapeutic strategy which combines an injection of patient's own activated lymphocytes to a classic immunotherapy with interferon-α and interleukin-2.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Collaborator: Ministry of Health, France

Criteria

Inclusion Criteria:

• Patients aged between 18 and 70 years

• Metastatic renal adenocarcinoma histologically proven

• Karnofsky performance status ≥ 70%

• Life expectation > 3 months

• At least one target, in a non-irradiated area

• Objective response or steady-state after a treatment with cytokines

• Informed written consent

Exclusion Criteria:

• Patients presenting more than one metastatic site with one hepatic metastasis diagnosed within the last 12 months

• White blood cells count < 2.5 G/L, Platelet count < 100 G/L

• Serum creatinine rate > 150 µmol/L

• Positive serology for : hepatitis B, hepatitis C, retrovirus

• Patient not available for a long-term follow-up

• Bellini duct tumor

• History of allograft or tumor within the five past years

• Severe cardiovascular, hepatic, renal or pulmonary troubles

• Auto-immune disease

• Severe infection

• Pregnancy or breast-feeding

• Corticotherapy