|
Interleukin-2 in Treating Patients With Metastatic Kidney Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Interleukin-2 in Treating Patients With Metastatic Kidney Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Interleukin-2 in Treating Patients With Metastatic Kidney Cancer Clinical research trials and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Interleukin-2 in Treating Patients With Metastatic Kidney Cancer. Interleukin-2 in Treating Patients With Metastatic Kidney Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Interleukin-2 in Treating Patients With Metastatic Kidney Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Interleukin-2 in Treating Patients With Metastatic Kidney Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Interleukin-2 in Treating Patients With Metastatic Kidney Cancer  Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
For Condition: renal clear cell carcinoma,recurrent renal cell cancer,stage 4 renal cell cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Ireland Cancer Center
Synopsis: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. PURPOSE: Phase IV trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer.
Details: OBJECTIVES: I. Determine the overall response rate, complete and partial response rates, and duration of response in patients with metastatic renal cell carcinoma treated with low-dose interleukin-2. II. Determine the overall survival, one-year progression-free survival, and two-year progression-free survival in patients treated with this regimen. III. Determine the incidence of adverse events in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive low-dose interleukin-2 subcutaneously 5 days a week for 6 weeks. Courses repeat every 9 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 464 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven metastatic renal cell carcinoma - Clear cell - Papillary - Sarcomatoid - Mixed Measurable or evaluable disease Evidence of disease following surgical resection of metastases No CNS disease --Prior/Concurrent Therapy-- Biologic therapy: - No prior recombinant human interleukin-2 - No concurrent interferon alfa Chemotherapy: No concurrent cytoxic chemotherapy Endocrine therapy: - No concurrent hormonal therapy (e.g., medroxyprogesterone) other than estrogen replacement therapy - No concurrent prophylactic glucocorticoids (replacement doses and topical use allowed) - No concurrent systemic corticosteroids Radiotherapy: - At least 4 weeks since prior radiotherapy - No prior radiotherapy to index lesion - No concurrent radiotherapy Surgery: - See Disease Characteristics - Prior surgery for renal cell carcinoma allowed Other: - No prior systemic therapy for renal cell carcinoma - At least 4 weeks since prior investigational drugs - No other concurrent investigational drugs or participation in another clinical study - No concurrent iodinated radiocontrast dye - No concurrent drugs for another indication that has purported activity in treatment of neoplasia (e.g., thalidomide) --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: - Hemoglobin at least 10 g/dL - WBC at least 4,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception (barrier plus 1 other method) - Thyroid-stimulating hormone normal - No known hypersensitivity or allergy to components of recombinant human interleukin-2 - No known autoimmune disease (e.g., Crohn's disease) - No other concurrent medical condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CindyConnell, Study Chair, Ireland Cancer Center
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Northwestern Connecticut Oncology-Hematology Associates
Torrington, Connecticut, 06790
United States
Additional Information:
Study ID Numbers: CDR0000068335; NCI-G00-1875,CHIR-MA-99-01,CWRU-CHIR-1899,CWRU-010002
Study Start Date: July 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006864
Other Renal Clear Cell Carcinoma Studies:
1. Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer
2. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
3. SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer
4. Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
5. Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer
Related Studies:
Other renal clear cell carcinoma Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
|
|
|
|
|
|
|
|
