Cytokines in Patients With Metastatic Renal Cell Carcinoma of Intermediate Prognosis

This study has been completed.
Sponsor:
Collaborators:
French Immunotherapy Intergroup
SCAPP (Sub-Cutaneous Administration Proleukin Program)
Information provided by:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT00291369
First received: February 13, 2006
Last updated: February 15, 2006
Last verified: February 2006
  Purpose

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.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: Interleukin-2
Drug: Interferon alfa
Drug: medroxyprogesterone acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PERCY QUATTRO: Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Progression-free survival
  • Objective response rate
  • Toxicity
  • Quality of life

Estimated Enrollment: 456
Study Start Date: December 1999
Estimated Study Completion Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00291369

Locations
France
Centre Leon Berard
Lyon, France, 69008
Sponsors and Collaborators
Centre Leon Berard
French Immunotherapy Intergroup
SCAPP (Sub-Cutaneous Administration Proleukin Program)
Investigators
Principal Investigator: Sylvie Negrier, MD, PhD Centre Leon Berard
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00291369     History of Changes
Other Study ID Numbers: PERCY QUATTRO, ET99-058
Study First Received: February 13, 2006
Last Updated: February 15, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
Metastatic renal cell carcinoma
Interleukin-2
Interferon alfa
Cytokines
Survival

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
Interferon-alpha
Interferons
Interleukin-2
Medroxyprogesterone Acetate
Medroxyprogesterone
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on August 20, 2014