Metastatic Renal Cell Carcinoma
Conditions
Keywords
Immunotherapy, Renal cell carcinoma, Metastasis, Lymphokine activated killers, Cell therapy
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.
Interventions
DRUGactivated lymphocytes
Sponsors
Ministry of Health, France
Rennes University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| - Disease free survival | — |
| - Overall survival | — |
| - Functional and phenotypic characteristics of injected cells | — |
| - Biological response | — |
Countries
France
Outcome results
None listed