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Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.

This study has been terminated.
Ministry of Health, France
Information provided by:
Rennes University Hospital Identifier:
First received: September 8, 2005
Last updated: December 30, 2005
Last verified: December 2005
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.

Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: activated lymphocytes
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Cell Carcinoma Treatment With Activated Tumor- Infiltrated Lymphocytes. A Non-Randomized Phase II Trial.

Resource links provided by NLM:

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • 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:
  • - Disease free survival
  • - Overall survival
  • - Functional and phenotypic characteristics of injected cells
  • - Biological response

Estimated Enrollment: 36
Study Start Date: December 2003
Estimated Study Completion Date: July 2005
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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00151645

Service d'Urologie - Hôpital Pontchaillou
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Study Director: Véronique Catros-Quemener, PharmD, PhD CHU Rennes
Study Chair: Eric Bellissant, MD, PhD CHU Rennes
Principal Investigator: François Guillé, MD CHU Rennes
  More Information

Publications: Identifier: NCT00151645     History of Changes
Other Study ID Numbers: AFSSAPS 990434
Study First Received: September 8, 2005
Last Updated: December 30, 2005

Keywords provided by Rennes University Hospital:
Renal cell carcinoma
Lymphokine activated killers
Cell therapy

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases processed this record on May 25, 2017