Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.

Phase 2

Terminated

• Conditions: Metastatic Renal Cell Carcinoma

• Registration Number: NCT00151645
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study Start: 2003-12
• Study Completion: 2005-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Status Verified: 2005-12
• Last Update Submitted: 2005-12-30
• Last Update Posted: 2006-01-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
- Disease free survival
- Overall survival
- Functional and phenotypic characteristics of injected cells
- Biological response

Trial Locations

Locations (1)

Service d'Urologie - Hôpital Pontchaillou; 🇫🇷 Rennes, France