Cytokines in Patients With Metastatic Renal Cell Carcinoma of Intermediate Prognosis

NCT00291369 | Completed Phase 3

• 2 other identifiers: PERCY QUATTROET99-058
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Metastatic renal cell carcinoma; Interleukin-2; Interferon alfa; Cytokines; Survival

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (4)

• Progression-free survival

• Objective response rate

• Toxicity

• Quality of life

Interventions

Interleukin-2 DRUG

Interferon alfa DRUG

medroxyprogesterone acetate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous treatment with cytokines.
• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead
• French Immunotherapy Intergroup: collaborator
• SCAPP (Sub-Cutaneous Administration Proleukin Program): collaborator

Study Sites (1)

Centre Leon Berard

Lyon, 69008, France

Location

Related Publications (3)

• 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.

  PMID: 9562581 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.

  PMID: 12436438 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.

  PMID: 12196373 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Interleukin-2; Interferon-alpha; Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Interferon Type I; Interferons; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sylvie Negrier, MD, PhD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2006
• First Posted: February 14, 2006
• Study Start: December 1, 1999
• Study Completion: February 1, 2005
• Last Updated: February 16, 2006

Record last verified: 2006-02

Locations

FR (1)