Cytokines in Patients With Metastatic Renal Cell Carcinoma of Intermediate Prognosis

Metastatic Renal Cell Carcinoma Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

• NCT number: NCT00291369
• Study type: Interventional
• Source: Centre Leon Berard
• Status: Completed
• Phase: Phase 3
• Start date: December 1999
• Completion date: February 2005