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A Randomized Three-Arm Study of the Treatment of Patients with Metastatic Renal Cell Carcinoma Using Low-Dose IL-2 and High-Dose IL-2 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 A Randomized Three-Arm Study of the Treatment of Patients with Metastatic Renal Cell Carcinoma Using Low-Dose IL-2 and High-Dose IL-2 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Randomized Three-Arm Study of the Treatment of Patients with Metastatic Renal Cell Carcinoma Using Low-Dose IL-2 and High-Dose IL-2 Clinical research trials and A Randomized Three-Arm Study of the Treatment of Patients with Metastatic Renal Cell Carcinoma Using Low-Dose IL-2 and High-Dose IL-2 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 A Randomized Three-Arm Study of the Treatment of Patients with Metastatic Renal Cell Carcinoma Using Low-Dose IL-2 and High-Dose IL-2. A Randomized Three-Arm Study of the Treatment of Patients with Metastatic Renal Cell Carcinoma Using Low-Dose IL-2 and High-Dose IL-2 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 A Randomized Three-Arm Study of the Treatment of Patients with Metastatic Renal Cell Carcinoma Using Low-Dose IL-2 and High-Dose IL-2 clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Randomized Three-Arm Study of the Treatment of Patients with Metastatic Renal Cell Carcinoma Using Low-Dose IL-2 and High-Dose IL-2 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 > "A" Clinical Trials Conditions > A Randomized Three-Arm Study of the Treatment of Patients with Metastatic Renal Cell Carcinoma Using Low-Dose IL-2 and High-Dose IL-2  A Randomized Three-Arm Study of the Treatment of Patients with Metastatic Renal Cell Carcinoma Using Low-Dose IL-2 and High-Dose IL-2
A Randomized Three-Arm Study of the Treatment of Patients with Metastatic Renal Cell Carcinoma Using Low-Dose IL-2 and High-Dose IL-2
For Condition: Neoplasm Metastasis,Renal Cell Carcinoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with metastatic renal cell carcinoma without effective available treatment options will be randomized in a three arm study to receive either two cycles of low-dose interleukin-2 daily, subcutaneous, outpatient IL-2 for 6 weeks (both with low expected toxicity) or two cycles of high-dose interleukin-2 (with possible requirement for ICU support and potential treatment-related mortality). Response rates, toxicity and overall survival will be evaluated in this randomized trial. At the completion of projected accrual, high and low dose bolus IL-2 will be compared and the less effective (or more toxic if no difference in efficacy is seen) regimen will be discontinued and accrual continue in the remaining two arms.
Details: Patients with metastatic renal cell carcinoma without effective available treatment options will be randomized in a three arm study to receive either two cycles of low-dose interleukin-2, daily subcutaneous, outpatient IL-2 for 6 weeks (both with low expected toxicity) or two cycles of high-dose interleukin-2 (with possible requirement for ICU support and potential treatment-related mortality). Response rates, toxicity and overall survival will be evaluated in this randomized trial.
Eligibility:
Study Type: Interventional, Treatment, Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Any patient with metastatic, measurable, historically-proven RCC without effective conventional treatment options. Expected survival greater than three months. Age greater than or equal to 18 years old. EXCLUSION CRITERIA: Second malignancy other than basal cell carcinoma or cervical carcinoma in situ. Significant psychiatric disease which in the opinion of the principal investigator would prevent adequate informed consent or render immunotherapy unsafe or contraindicated. Serum creatinine or total bilirubin greater than normal limits. Requirement for steroid administration. Prior therapy within 28 days. Systemic infections, coagulation disorders or site of bleeding. ECOG performance status greater than or equal to 2. Pregnancy. Previous IL-2 therapy. Positive HIV antibody titer. FEV(1) or VC less than or equal to 65% predicted (pulmonary function screening to be done in patients with significant smoking history or suspicion of pulmonary disease by history or examination). Abnormal stress cardiac exam (to be done in all patients greater than or equal to 50 years old and others as indicated clinically) or a significantly abnormal EKG will be excluded. Greater than 25% estimated hepatic replacement by tumor or a SGOT or SGPT greater than 3 times normal. Tumor involvement of the CNS or major nerve compression .
Total Enrollment: 400
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 910094; 91-C-0094
Study Start Date: March 22, 1991
Record last reviewed: January 24, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001268
Other Neoplasm Metastasis Studies:
1. SU-011,248 in the Treatment of Patients with Cytokine-Refractory Metastatic Renal Cell Carcinoma
2. A research study in patients with renal cancer to determine the safety and effectiveness of a new investigational drug called ABX-EGF.
3. Active Immunotherapy Of Metastatic Renal Cell Carcinoma Using Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA
4. Survival Study Of Oncophage® vs. Observation In Patients with Kidney Cancer
5. Stem Cell Transplant for Advanced Renal Cell Cancer
Related Studies:
Other Neoplasm Metastasis Clinical Trials
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A Randomized Three-Arm Study of the Treatment of Patients with Metastatic Renal Cell Carcinoma Using Low-Dose IL-2 and High-Dose IL-2
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