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Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer Clinical research trials and Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer. Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer  Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
For Condition: stage 3 renal cell cancer,stage 4 renal cell cancer
Status: No longer recruiting
Sponsor(s): Cytokine Working Group ,
Synopsis: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with no further therapy in treating patients with stage III or stage IV kidney cancer.
Details: OBJECTIVES: I. Compare the disease-free and overall survival of patients with stage III or IV high-risk renal cell carcinoma treated with adjuvant high-dose interleukin-2 vs observation alone. II. Determine the overall tolerability, toxicity, and safety of adjuvant high-dose interleukin-2 in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease classification (T3b (N0) or N1 (T1-3b) vs T3c or T4 (N0-1) vs N2 or N3 disease (T1-4) vs M1 disease resected to no evaluable disease). Within 3-12 weeks after radical nephrectomy and/or resection of metastases, patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive high-dose interleukin-2 IV over 15 minutes every 8 hours on days 1-5 and 15-19 for a maximum of 28 doses. Arm II: Patients undergo observation alone. Patients may receive treatment as in arm I beginning at the first sign of recurrence. Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven high-risk renal cell carcinoma that has been completely resected within the past 12 weeks; T3b (N0); N1 (T1-3b); T3c or T4 (N0-1); N2 or N3 (T1-4) disease OR M1 disease resected to no evaluable disease - Postoperative radiographic evaluation must reveal no evidence of detectable residual disease - No ascites or pleural effusions - No detectable metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior interleukin-2 for renal cell carcinoma - Chemotherapy: No prior systemic chemotherapy for renal cell carcinoma - Endocrine therapy: No concurrent steroids - Radiotherapy: Prior locoregional radiotherapy to solitary resectable metastases allowed - Surgery: See Disease Characteristics; Recovered from prior surgical resection; No prior organ allografts - Other: No other prior systemic therapy for renal cell carcinoma --Patient Characteristics-- - Age: 16 and over - Performance status: ECOG 0-1 OR Karnofsky 80-100% - Life expectancy: Not specified - Hematopoietic: WBC at least 4,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin no greater than 1.5 mg/dL - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: No congestive heart failure; No symptoms of coronary artery disease; No serious cardiac arrhythmias; No prior myocardial infarction; Normal cardiac stress test required if over age 40 - Pulmonary: FEV1 greater than 2.0 liters or at least 75% predicted for height and age; No chronic obstructive pulmonary disease - Other: HIV negative; No significant detectable infection; No other significant medical disease; No other invasive malignancy within the past 5 years except surgically cured nonmelanomatous skin cancer or carcinoma in situ or stage I carcinoma of the cervix; No contraindication to pressor agents; No seizure disorder; No psychiatric illness that would preclude informed consent; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JosephClark, Study Chair, Cytokine Working Group
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Summit Medical Center
Oakland, California, 94609
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, 97213-2967
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Our Lady of Mercy Medical Center
Bronx, New York, 10466
United States
Additional Information:
Study ID Numbers: CDR0000065887; CWG-LU-8520,NCI-V97-1351
Study Start Date: June 1997
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003126
Other Stage 4 Renal Cell Cancer Studies:
1. Interferon alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
2. Interleukin-2, Vinblastine, and GM-CSF in Treating Patients With Metastatic Kidney Cancer
3. Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer
4. Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer
5. Vaccine Therapy in Treating Patients With Kidney Cancer
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
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