Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.

Conditions
-----------------
Metastatic Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: activated lymphocytes


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: activated lymphocytes|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate: partial or complete response during at least 4 weeks from week 22 after the beginning of the first cycle of cytokines. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Disease free survival |  |  | 
| - Overall survival |  |  | 
| - Functional and phenotypic characteristics of injected cells |  |  | 
| - Biological response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunotherapy, Renal cell carcinoma, Metastasis, Lymphokine activated killers, Cell therapy