Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate: partial or complete response during at least 4 weeks from week 22 after the beginning of the first cycle of cytokines.
Véronique Catros-Quemener, PharmD, PhD
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)