Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00151645
First received: September 8, 2005
Last updated: December 30, 2005
Last verified: December 2005
  Purpose

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
Endpoint Classification: Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151645

Locations
France
Service d'Urologie - Hôpital Pontchaillou
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
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:
ClinicalTrials.gov Identifier: NCT00151645     History of Changes
Other Study ID Numbers: AFSSAPS 990434, PHRC/02-06, CIC0203/013
Study First Received: September 8, 2005
Last Updated: December 30, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014