Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.|
- Objective response rate: partial or complete response during at least 4 weeks from week 22 after the beginning of the first cycle of cytokines.
- - Disease free survival
- - Overall survival
- - Functional and phenotypic characteristics of injected cells
- - Biological response
|Study Start Date:||December 2003|
|Estimated Study Completion Date:||July 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151645
|Service d'Urologie - Hôpital Pontchaillou|
|Rennes, France, 35033|
|Study Director:||Véronique Catros-Quemener, PharmD, PhD||CHU Rennes|
|Study Chair:||Eric Bellissant, MD, PhD||CHU Rennes|
|Principal Investigator:||François Guillé, MD||CHU Rennes|