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| Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer University of Glasgow |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00053807 |
Purpose
RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining interferon alfa and interleukin-2 with fluorouracil may kill any remaining tumor cells following surgery. It is not yet known whether combining interferon alfa and interleukin-2 with fluorouracil is more effective than observation after surgery for kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combining interleukin-2, interferon alfa, and fluorouracil to that of observation alone in treating patients who have undergone surgery for kidney cancer and are at high risk of relapse.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: aldesleukin Biological: recombinant interferon alfa Drug: fluorouracil Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Adjuvant Interleukin-2, Interferon-Alpha and 5-Fluorouracil for Patients With High Risk of Relapse After Surgical Treatment for Renal Cell Carcinoma |
| Study Start Date: | February 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and at 2 and 6 months after randomization.
Patients are followed monthly for 3 months (arm I only), every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary renal cell carcinoma meeting 1 of the following criteria:
Underwent surgical resection of primary tumor within the past month
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Austria | |
| Kaiser Franz Josef Hospital | |
| Vienna, Austria, A-1100 | |
| Belgium | |
| AZ Groeninge - Campus St. Maarten | |
| Kortrijk, Belgium, 8500 | |
| Onze Lieve Vrouw Ziekenhuis Aalst | |
| Aalst, Belgium, B-9300 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Universitair Ziekenhuis Gent | |
| Ghent, Belgium, B-9000 | |
| Hungary | |
| National Institute of Oncology | |
| Budapest, Hungary, 1125 | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 30196 | |
| Italy | |
| Ospedale di Circolo e Fondazione Macchi | |
| Varese, Italy, 21100 | |
| Netherlands | |
| Academisch Ziekenhuis Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Akademisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Daniel Den Hoed Cancer Center at Erasmus University Medical Center | |
| Rotterdam, Netherlands, 3075 EA | |
| Jeroen Bosch Ziekenhuis | |
| Hertogenbosch, Netherlands, 5211 NL | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands, 1091 HA | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, 6500 HB | |
| Turkey | |
| Dokuz Eylul University School of Medicine | |
| Izmir, Turkey, 35340 | |
| Marmara University Hospital | |
| Istanbul, Turkey, 81190 | |
| United Kingdom, Scotland | |
| Beatson Institute for Cancer Research - Glasgow | |
| Glasgow, Scotland, United Kingdom, G61 1BD | |
| Investigator: | Pieter H. M. de Mulder, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
| Investigator: | Hein van Poppel, MD, PhD | U.Z. Gasthuisberg |
| Investigator: | Paul A. Vasey, MD | Beatson Institute for Cancer Research - Glasgow |
More Information
| Study ID Numbers: | CDR0000269479, EORTC-30955 |
| Study First Received: | February 5, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00053807 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III renal cell cancer stage IV renal cell cancer |
|
Antimetabolites Urinary Tract Neoplasm Interferon Type I, Recombinant Immunologic Factors Urogenital Neoplasms Urologic Neoplasms Renal Cancer Anti-Retroviral Agents Urologic Diseases Kidney Neoplasms Analgesics Kidney Diseases Interferon-alpha Kidney Cancer Anti-HIV Agents |
Interferons Adjuvants, Immunologic Antiviral Agents Angiogenesis Inhibitors Immunosuppressive Agents Carcinoma Aldesleukin Analgesics, Non-Narcotic Interleukin-2 Fluorouracil Carcinoma, Renal Cell Peripheral Nervous System Agents Adenocarcinoma Interferon Alfa-2a Neoplasms, Glandular and Epithelial |
|
Antimetabolites Anti-Infective Agents Interferon Type I, Recombinant Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Anti-Retroviral Agents Urologic Diseases Sensory System Agents Kidney Neoplasms |
Therapeutic Uses Analgesics Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases Interferon-alpha Anti-HIV Agents Neoplasms by Histologic Type Growth Substances Interferons Adjuvants, Immunologic Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions |