Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.

Rennes University Hospital

Status and phase: Terminated; Phase 2

Conditions: Metastatic Renal Cell Carcinoma

Treatments: Drug: activated lymphocytes

Study type: Interventional

Funder types: Other

Identifiers

NCT00151645

AFSSAPS 990434

CIC0203/013

PHRC/02-06

Details and patient eligibility

About

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.

Full description

Phase I and II trials for the treatment of melanoma or renal cell carcinoma have already evaluated lymphokine-activated killer cells and tumor-infiltrating cells. In metastatic renal cell carcinoma, these therapies have shown some complete responses and a low 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. A secondary objective is to improve cell preparation methods and to characterize functionally and phenotypically injected cells.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)