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Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV 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 Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer Clinical research trials and Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV 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 Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer. Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV 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 Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV 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.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer  Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer
Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer
For Condition: stage 4 renal cell cancer
Status: Recruiting
Sponsor(s): H. Lee Moffitt Cancer Center and Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer.
Details: OBJECTIVES: - Determine the percentage of patients with stage IV renal cell carcinoma with a reduction in tumor size after treatment with B7-1 gene-modified autologous tumor cell vaccine and interleukin-2. - Determine the immunogenicity of this regimen in these patients. - Determine the overall survival of patients treated with this regimen. - Determine the local and systemic toxicity of this regimen in these patients. OUTLINE: Tumor tissue for vaccine preparation is obtained when patients undergo palliative surgical resection of primary tumor or therapeutic resection of metastasis. At approximately 3-6 weeks after surgery, patients receive B7-1 gene-modified autologous tumor cell vaccine subcutaneously (SC) once on days 1, 29, and 57. At 6 weeks after the first vaccination, patients receive interleukin-2 (IL-2) SC five days a week for 6 weeks (days 43-82). Patients with stable or responding disease after day 106 may receive additional vaccinations in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks after the last dose of IL-2. PROJECTED ACCRUAL: Approximately 30 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 stage IV renal cell carcinoma - Symptomatic primary tumor or resectable metastasis - Measurable disease post resection - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC greater than 4,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 10 g/dL - Hematocrit greater than 30% Hepatic: - Bilirubin less than 2 times normal - SGOT less than 3 times normal Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No evidence of active myocardial ischemia, prior myocardial infarction, or arrhythmia Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No contraindications to surgical resection - No history of immunodeficiency disease - No known allergy to penicillin PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior interleukin-2, interferon alfa, or other biologic agent allowed Chemotherapy: - Not specified Endocrine therapy: - No concurrent corticosteroids (except for replacement doses for adrenal insufficiency) Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - No concurrent immunosuppressants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottAntonia, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612
United States
Recruiting Scott Antonia 813-972-8400, ext. 2677
Additional Information:
Study ID Numbers: CDR0000068260; NCI-G00-1872,NCI-5090,MCC-IRB-5620,MCC-12207
Study Start Date:
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031564
Other Stage 4 Renal Cell Cancer Studies:
1. Interferon alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer
2. Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
3. BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
4. Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer
5. PEG-Interferon alfa-2b in Treating Patients With Metastatic Kidney Cancer
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer
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