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Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer Clinical research trials and Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer. Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer  Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer
Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer
For Condition: stage 4 renal cell cancer,stage 2 renal cell cancer,recurrent renal cell cancer,stage 3 renal cell cancer,drug extravasation,stage 1 renal cell cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Biomed 101 may protect normal cells from the side effects of interleukin-2. PURPOSE: Phase I trial to study the effectiveness of Biomed 101 in treating patients receiving interleukin-2 for kidney cancer.
Details: OBJECTIVES: I. Evaluate the safety and maximum tolerated dose of Biomed 101 in patients with renal cell cancer currently treated with interleukin-2 (IL-2). II. Evaluate the effect of different doses of Biomed 101 on the incidence and severity of IL-2 related toxicities and on the incidence and frequency of IL-2 dose reduction due to IL-2 induced toxicity. PROTOCOL OUTLINE: This is a dose escalation study of Biomed 101. Patients receive oral Biomed 101 three times daily, followed by interleukin-2 IV on days 1-5 and 16-20. Cohorts of 5 patients receive escalating doses of Biomed 101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicities. Patients are followed for 1 month. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed renal cell cancer - No CNS metastases --Prior/Concurrent Therapy-- - At least 30 days since prior investigational drugs; No other concurrent investigational drugs; No intubation required for greater than 72 hours; No prior enrollment in this study --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: At least 12 weeks - Hematopoietic: WBC at least 2,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: No hepatic failure; No encephalopathy; Bilirubin no greater than 2.5 times upper limit of normal (ULN); AST or ALT no greater than 2.5 times ULN - Renal: No renal dysfunction requiring dialysis for greater than 72 hours; Creatinine no greater than 2.0 mg/dL - Cardiovascular: No history of sustained ventricular tachycardia (greater than 5 beats); No uncontrolled cardiac rhythm disturbances; No recurrent chest pain with echocardiogram changes; No angina; No myocardial infarction; No pericardial tamponade; No moderate or severe coronary artery disease (New York Heart Association class 3 or 4) - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No significant neurological dysfunction including seizure or clinical signs of other significant neurological disease; No gastrointestinal bleeding requiring surgery; No concurrent infection requiring antimicrobial therapy; No bowel ischemia or perforation
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertFiglin, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000067566; UCLA-9908051,NCI-G00-1708,BIOMED-101-CLP-01
Study Start Date: December 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004890
Other Stage 4 Renal Cell Cancer Studies:
1. Kidney-Sparing Surgery Compared With Kidney Removal in Treating Patients With Kidney Cancer
2. Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer
3. Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer
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