Status:
TERMINATED
Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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, in...
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, t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00151645
Start Date
December 1 2003
End Date
July 1 2005
Last Update
January 2 2006
Active Locations (1)
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1
Service d'Urologie - Hôpital Pontchaillou
Rennes, France, 35033