Cytokines in Patients With Metastatic Renal Cell Carcinoma of Intermediate Prognosis

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Collaborators: French Immunotherapy Intergroup; SCAPP (Sub-Cutaneous Administration Proleukin Program)
• Treatments: Interferon-alpha; Interferons; Interleukin-2; Medroxyprogesterone; Medroxyprogesterone Acetate

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.