Efficacy of Activated Lymphocytes in Renal Cell Carcinoma.

December 30, 2005 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Service d'Urologie - Hôpital Pontchaillou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
- Disease free survival
- Overall survival
- Functional and phenotypic characteristics of injected cells
- Biological response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Ministry of Health, France

Investigators

  • Study Director: Véronique Catros-Quemener, PharmD, PhD, CHU Rennes
  • Principal Investigator: François Guillé, MD, CHU Rennes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Estimate)

January 2, 2006

Last Update Submitted That Met QC Criteria

December 30, 2005

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFSSAPS 990434
  • PHRC/02-06
  • CIC0203/013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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