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Sponsors and Collaborators: |
Centre Leon Berard French Immunotherapy Intergroup SCAPP (Sub-Cutaneous Administration Proleukin Program) |
Information provided by: | Centre Leon Berard |
ClinicalTrials.gov Identifier: | NCT00291369 |
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 III |
Drug Information available for: | Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Medroxyprogesterone Medroxyprogesterone 17-acetate Interleukin-2 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | PERCY QUATTRO: Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis |
Estimated Enrollment: | 456 |
Study Start Date: | December 1999 |
Estimated Study Completion Date: | February 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |||||
Centre Leon Berard | |||||
Lyon, France, 69008 |
Centre Leon Berard |
French Immunotherapy Intergroup |
SCAPP (Sub-Cutaneous Administration Proleukin Program) |
Principal Investigator: | Sylvie Negrier, MD, PhD | Centre Leon Berard |
link to abstract presented at 2005 ASCO annual meeting 
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Study ID Numbers: | PERCY QUATTRO, ET99-058 |
First Received: | February 13, 2006 |
Last Updated: | February 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00291369 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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