Cytokines in Patients With Metastatic Renal Cell Carcinoma of Intermediate Prognosis
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PERCY QUATTRO: Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis |
- Overall survival
- Progression-free survival
- Objective response rate
- Toxicity
- Quality of life
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| France | |
| Centre Leon Berard | |
| Lyon, France, 69008 | |
| Principal Investigator: | Sylvie Negrier, MD, PhD | Centre Leon Berard |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00291369 History of Changes |
| Other Study ID Numbers: | PERCY QUATTRO, ET99-058 |
| Study First Received: | February 13, 2006 |
| Last Updated: | February 15, 2006 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Leon Berard:
|
Metastatic renal cell carcinoma Interleukin-2 Interferon alfa Cytokines Survival |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Interferon-alpha Interferon Alfa-2a Interferons |
Interleukin-2 Medroxyprogesterone Acetate Medroxyprogesterone Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Analgesics, Non-Narcotic |
ClinicalTrials.gov processed this record on May 16, 2013