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Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.

Phase 2
18 Years
70 Years
Not Enrolling
Metastatic Renal Cell Carcinoma

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Trial Information

Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate: partial or complete response during at least 4 weeks from week 22 after the beginning of the first cycle of cytokines.

Principal Investigator

Véronique Catros-Quemener, PharmD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

CHU Rennes


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

AFSSAPS 990434



Start Date:

December 2003

Completion Date:

July 2005

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Immunotherapy
  • Renal cell carcinoma
  • Metastasis
  • Lymphokine activated killers
  • Cell therapy
  • Carcinoma
  • Carcinoma, Renal Cell