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Interferon alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Interferon alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Interferon alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer Clinical research trials and Interferon alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Interferon alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer. Interferon alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Interferon alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer clinical trial. Subjects frequently get the best healthcare possible for their Interferon alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Interferon alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer  Interferon alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
Interferon alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
For Condition: stage 4 renal cell cancer
Status: Recruiting
Sponsor(s): Medical Research Council , EORTC Genito-Urinary Tract Cancer Cooperative Group
Synopsis: 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 with interleukin-2 and fluorouracil may kill more tumor cells. It is not yet known whether interferon alfa is more effective with or without interleukin-2 and fluorouracil in treating metastatic kidney cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of interferon alfa combined with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who have advanced metastatic kidney cancer.
Details: OBJECTIVES: - Compare progression-free and overall survival of patients with advanced metastatic renal carcinoma treated with interferon alfa with or without interleukin-2 and fluorouracil. - Compare the toxicity of these regimens in these patients. - Assess the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I (Interferon alfa monotherapy): Patients receive interferon alfa subcutaneously (SC) on days 1, 3, and 5. Treatment continues weekly for at least 9 weeks in the absence of disease progression or unacceptable toxicity. - Arm II (Interferon alfa, interleukin-2, and fluorouracil combination therapy): Patients receive interferon alfa SC on day 1 of weeks 1 and 4 and days 1, 3, and 5 of weeks 2, 3, 5, 6, 7, and 8. Patients also receive interleukin-2 SC twice daily on days 3-5 of weeks 1 and 4 and once daily on days 1, 3, and 5 of weeks 2 and 3. Patients then receive fluorouracil IV on day 1 of weeks 5-8. Treatment repeats every 10 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at 9, 19, and 26 weeks, and then at 8 months. Patients are followed at 8, 10, and 12 months, every 4 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 670 patients (335 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/81 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed renal cell carcinoma - Advanced metastatic disease that requires treatment - Measurable disease (single bone lesions not included) - No brain metastasis PATIENT CHARACTERISTICS: Age - 18 to 81 Performance status - WHO 0-1 Life expectancy - More than 12 weeks Hematopoietic - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 10 g/dL Hepatic - Not specified Renal - Not specified Cardiovascular - No myocardial infarction within the past 6 months - No unstable angina pectoris Other - Not pregnant or nursing - Fertile patients must use effective contraception during and for at least 6 months after study participation - No other concurrent disease or prior malignancy that would preclude study treatments or comparisons - No concurrent active infection requiring antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy Chemotherapy - No prior chemotherapy Endocrine therapy - No prior endocrine therapy - No concurrent corticosteroids Radiotherapy - At least 4 weeks since prior radiotherapy Surgery - Prior resection of the primary tumor recommended but not required - No prior major organ allografts
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MartinGore, , Royal Marsden NHS Trust
Universitaetsklinikum Bonn *Recruiting*
Bonn, , D-53105
Germany
Recruiting Contact Person 49-280-3816
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-332-211
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-821-3000
National Cancer Institute - Bratislava *Recruiting*
Bratislava, , 833 10
Slovakia
Recruiting Contact Person 421-593-78-111
Onze Lieve Vrouw Ziekenhuis Aalst *Recruiting*
Aalst, , B-9300
Belgium
Recruiting Contact Person 32-785-353
Nijmegen University Cancer Centre *Recruiting*
Nijmegen, , 6500 HB
Netherlands
Recruiting Contact Person 31-439-1911
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-541-3111
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-46-39-222
University Medical Center Nijmegen *Recruiting*
Nijmegen, , 6500 HB
Netherlands
Recruiting Contact Person 31-24-3611111
Additional Information:
Study ID Numbers: CDR0000269480; ISRCTN46518965,MRC-RE04,EORTC-30012,EU-20231
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053820
Other Stage 4 Renal Cell Cancer Studies:
1. Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer
2. Interferon alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer
3. Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer
4. Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer
5. Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer
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Other stage 4 renal cell cancer Clinical Trials
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Interferon alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
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