Cytokines in Patients With Metastatic Renal Cell Carcinoma of Intermediate Prognosis

February 15, 2006 updated by: Centre Leon Berard

PERCY QUATTRO: Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis

The PERCY Quattro trial has been designed to evaluate the survival benefit of two cytokine treatments, Interleukin-2 (IL2) and/or alpha interferon (IFN), for patients with intermediate chance of response in metastatic renal cell carcinoma.

Eligible patients will be randomly assigned in a two-by-two factorial design to either medroxyprogesterone (MPA), subcutaneous IFN, subcutaneous IL2, or a combination of IFN and IL2.

The primary objective of the study is overall survival; secondary objectives are progression-free survival, response rate, toxicity, and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The PERCY Quattro trial has been designed to evaluate the survival benefit of Interleukin-2 (IL2) and/or alpha interferon (IFN) for patients with intermediate chance of response in metastatic renal cell carcinoma.

The primary objective is overall survival, and secondary objectives are progression-free survival, response rate, toxicity, and quality of life assessed before and after induction treatment (week 10).

Patients above 18 years of age are eligible if they have histologically confirmed, clearly progressive metastatic renal carcinoma, more than one metastatic organ and good performance status (Karnofsky score ≥80%), or one metastatic organ with Karnofsky score 80%, normal blood and liver functions with creatinine level <= 160 µmol/L.

Eligible patients will be randomly assigned in a two-by-two factorial design to either medroxyprogesterone (MPA), subcutaneous IFN, subcutaneous IL2, or a combination of IFN and IL2. The planned sample size is 456 patients (114 in each of the four arms). MPA is given orally as 200 mg daily. IFN is given subcutaneously as 9 million IU three times a week. IL2 is given subcutaneously on a four-week schedule: 9 million IU twice daily for five days followed by a two-day rest, then, on the following three weeks, 9 million IU twice daily for two days then 9 million IU once daily on the following three days; after a week of rest, an identical 4-week cycle is administered. IFN and IL2 combination is given using identical routes, schedules and doses except for a reduction of IFN dose to 6 million IU per injection.

Study Type

Interventional

Enrollment

456

Phase

  • Phase 3

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
      • Lyon, France, 69008
        • Centre Leon Berard

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Progressive histologically proven metastatic renal cell carcinoma.
  • Patient with only 1 metastatic site and Karnofsky = 80% or more than 1 metastatic site and Karnofsky >= 80%.
  • Age >= 18
  • No wide-field radiation therapy for 6 weeks at least.
  • No active brain metastasis.
  • Blood values within limits of normal (hematocrit > 30% and leukocyte count >= 4x109/l and platelet count >= 120x109/l).
  • Creatinine < 150 µmol/l and bilirubin <= normal.
  • Female patients of childbearing potential: effective method of contraception is necessary.
  • Written, voluntary, informed consent.

Exclusion Criteria:

  • Previous treatment with cytokines.
  • Only one metastatic organ and Karnofsky = 90% or 100% (inclusion in good prognosis group).
  • More than one metastatic organ (at least one metastasis to the liver) and <12 months between initial diagnosis and diagnosis of metastasis.
  • Active brain metastases.
  • Patient with concurrent grade III/IV heart disorder (congestive heart failure, coronary artery disease, uncontrolled hypertension, severe arrhythmia, etc) and/or stroke volume < 50%.
  • Severe pulmonary, hepatic, or renal disease potentially aggravated by treatment.
  • Severe concurrent infection necessitating antibiotics
  • Patient with known HIV or AIDS-related disease, or presence of HB antigen or known chronic hepatitis.
  • Previous allograft.
  • Patient under corticosteroid treatment.
  • Previous or concurrent primary malignancies at other sites (except from baso-cellular skin cancer or cervical cancer in situ)
  • Pregnant or lactating woman.
  • Follow-up difficult because of geography or personal circumstances.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Toxicity
Progression-free survival
Quality of life
Objective response rate

Collaborators and Investigators

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

Sponsor

Centre Leon Berard

Collaborators

French Immunotherapy Intergroup
SCAPP (Sub-Cutaneous Administration Proleukin Program)

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, 1999

Study Completion

February 1, 2005

Study Registration Dates

First Submitted

February 13, 2006

First Submitted That Met QC Criteria

February 13, 2006

First Posted (ESTIMATE)

February 14, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 16, 2006

Last Update Submitted That Met QC Criteria

February 15, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERCY QUATTRO
  • ET99-058

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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