Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.

R

Rennes University Hospital

Status and phase

Terminated
Phase 2

Conditions

Metastatic Renal Cell Carcinoma

Treatments

Drug: activated lymphocytes

Study type

Interventional

Funder types

Other

Identifiers

NCT00151645
AFSSAPS 990434
CIC0203/013
PHRC/02-06

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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