drugset / Trial / NCT00291369
Cytokines in Patients With Metastatic Renal Cell Carcinoma of Intermediate Prognosis
Phase 3
Completed
456 enrolled
Centre Leon Berard
French Immunotherapy Intergroup · collabSCAPP (Sub-Cutaneous Administration Proleukin Program) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 1999-12
- Primary completion
- —
- Completion
- 2005-02
Publications
- Background Negrier S, Escudier B, Lasset C, Douillard JY, Savary J, Chevreau C, Ravaud A, Mercatello A, Peny J, Mousseau M, Philip T, Tursz T. Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Francais d'Immunotherapie. N Engl J Med. 1998 Apr 30;338(18):1272-8. doi: 10.1056/NEJM199804303381805.
- Background Ravaud A, Delva R, Gomez F, Chevreau C, Douillard JY, Peny J, Coudert B, Negrier S; Groupe Francais d'Immunotherapie. Subcutaneous interleukin-2 and interferon alpha in the treatment of patients with metastatic renal cell carcinoma-Less efficacy compared with intravenous interleukin-2 and interferon alpha. Results of a multicenter Phase II trial from the Groupe Francais d'Immunotherapie. Cancer. 2002 Dec 1;95(11):2324-30. doi: 10.1002/cncr.10968.
- Background Negrier S, Escudier B, Gomez F, Douillard JY, Ravaud A, Chevreau C, Buclon M, Perol D, Lasset C. Prognostic factors of survival and rapid progression in 782 patients with metastatic renal carcinomas treated by cytokines: a report from the Groupe Francais d'Immunotherapie. Ann Oncol. 2002 Sep;13(9):1460-8. doi: 10.1093/annonc/mdf257.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | aldesleukin | Protein / enzyme biologic | 9 iu | Subcutaneous |
| Subject | interferon alfa | Protein / enzyme biologic | 6 iu | Subcutaneous |
| Subject | interferon alfa | Protein / enzyme biologic | 9 iu | Subcutaneous |
| Subject | medroxyprogesterone acetate | Other / unclassified | 200 mg | Oral |