Status:
COMPLETED
Cytokines in Patients With Metastatic Renal Cell Carcinoma of Intermediate Prognosis
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
French Immunotherapy Intergroup
SCAPP (Sub-Cutaneous Administration Proleukin Program)
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 respo...
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 ce...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT00291369
Start Date
December 1 1999
End Date
February 1 2005
Last Update
February 16 2006
Active Locations (1)
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1
Centre Leon Berard
Lyon, France, 69008