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High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2 Clinical research trials and High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2 health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2. High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2 Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2 clinical trial. Test subjects typically receive the most expert healthcare available for their High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2 condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2  High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2
High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2
For Condition: stage 4 renal cell cancer,recurrent renal cell cancer
Status: Recruiting
Sponsor(s): Blumenthal Cancer Center at Carolinas Medical Center ,
Synopsis: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill renal cell carcinoma (kidney cancer) cells. PURPOSE: Phase II trial to study the effectiveness of high-doseintravenous interleukin-2 in treating patients who have metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.
Details: OBJECTIVES: - Determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (IL-2) when treated with high-dose intravenous IL-2. - Determine the overall survival, disease-free survival, and time to progression in patients treated with this drug. - Determine the toxicity of this drug in these patients. OUTLINE: This is a pilot study. Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses (course 1). Patients are assesed for response 2 months after initiation of treatment. Patients with responding or stable disease receive a second course of therapy. Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity. Patients are followed every 6 months for survival. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed renal cell carcinoma - Metastatic disease - No pure papillary or sarcomatoid variants - Measurable disease - Failed prior subcutaneous OR intravenous (dose 50,000 IU/kg/day) interleukin-2 - Documented disease progression - No estimated hepatic replacement by tumor > 25% by CT scan or MRI - No tumor involving the CNS or a major nerve PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 80-100% Life expectancy - More than 3 months Hematopoietic - Platelet count 80,000/mm^3 - No sites of ongoing bleeding Hepatic - See Disease Characteristics - Bilirubin 1.4 mg/dL - AST and ALT 3 times normal - PT or PTT INR 1.2 - Hepatitis B surface antigen negative - Hepatitis C virus negative - No coagulation disorders Renal - Creatinine 1.6 mg/dL Cardiovascular - No ongoing ischemia* - No cardiac dysfunction* - No abnormal ejection fraction* NOTE: *A cardiac stress test is indicated for all patients 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram Pulmonary - FEV_1 65% of predicted* - Vital capacity 65% of predicted* NOTE: *Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph Other - HIV negative - No AIDS - No systemic infections - No other malignancy except carcinoma in situ - No psychiatric illness that would preclude study participation or compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - Not specified Endocrine therapy - No concurrent steroids Radiotherapy - Not specified Surgery - Not specified Other - More than 28 days since other prior treatment for renal cell cancer - No concurrent immunosuppressive agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardWhite, Study Chair, Blumenthal Cancer Center at Carolinas Medical Center
Blumenthal Cancer Center at Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28232-2861
United States
Recruiting Richard White 704-355-2884
Additional Information:
Study ID Numbers: CDR0000357581; CMC-10-01-01AH
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080977
Other Stage 4 Renal Cell Cancer Studies:
1. Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
2. ZD 1839 in Treating Patients With Metastatic Kidney Cancer
3. Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
4. Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
5. Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other North Carolina Clinical Trials
Other Charlotte Clinical Trials
High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2
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