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Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer health trials occur in a lot of 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 potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer. Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer clinical trial. Human subjects often get the best healthcare possible for their Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer  Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer
Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer
For Condition: stage 4 renal cell cancer,stage 3 renal cell cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Duke Comprehensive Cancer Center
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV kidney cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of autologous dendritic cells transfected with autologous total tumor RNA in patients with stage III or IV renal cell carcinoma. II. Assess the toxicity and feasibility of this treatment regimen in these patients. III. Evaluate this regimen in terms of cellular immune response, clinical response, and overall survival in these patients. PROTOCOL OUTLINE: This is a dose-escalation study. Patients undergo nephrectomy for tumor RNA extraction followed by leukapheresis to collect peripheral blood mononuclear cells for dendritic cell (DC) production. Patients receive autologous DC transfected with autologous renal cell carcinoma RNA both IV and intradermally on weeks 0, 2, and 4. Cohorts of 3-6 patients receive escalating doses of DC IV until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study over 24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage III or IV renal cell carcinoma scheduled for resection of primary renal tumor - No CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: At least 6 weeks since prior immunotherapy (e.g., interleukin-2, interferon alfa, or autolymphocyte therapy); No other concurrent immunotherapy - Chemotherapy: At least 6 weeks since prior chemotherapy and recovered; No concurrent chemotherapy - Endocrine therapy: At least 6 weeks since prior steroid therapy and recovered; No concurrent steroid therapy - Radiotherapy: At least 6 weeks since prior radiotherapy and recovered; No concurrent local or palliative radiotherapy - Surgery: See Disease Characteristics; At least 6 weeks since other prior major surgery and recovered; No prior radical nephrectomy - Other: No concurrent immunosuppressive agents (e.g., azathioprine or cyclosporine) --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: At least 6 months - Hematopoietic: WBC at least 3,000/mm3; Hemoglobin at least 9 mg/dL (transfusion independent); Platelet count at least 100,000/mm3; No history of bleeding disorder or other blood dyscrasias - Hepatic: Bilirubin less than 2.0 mg/dL; PT less than 1.5 times control; No serious hepatic disease - Renal: Creatinine no greater than 2.5 mg/dL; Calcium less than 12 mg/dL; No symptomatic hypercalcemia - Cardiovascular: No serious cardiac disease (e.g., New York Heart Association class III or IV heart disease); No deep vein thrombosis - Pulmonary: No serious pulmonary disease (e.g., asthma or chronic obstructive pulmonary disease); No pulmonary embolism - Other: No serious chronic or acute illness that would preclude study; No autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis); No psychological impediment that would preclude study; No prior malignancy within past 5 years except basal cell carcinoma, carcinoma in situ of the cervix, nonmelanomatous skin cancer, controlled superficial bladder cancer, or surgically or radiologically treated prostatic adenocarcinoma with no evidence of rising PSA for at least 12 months after treatment; No active acute or chronic infection (e.g., symptomatic urinary tract infection, surgical site infection, or viral hepatitis); HIV negative; Must have adequate peripheral vein access; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohannesVieweg, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000067820; DUMC-GCRC-839,NCI-G00-1787,DUMC-1862-99-10,DUMC-DORIS-99124
Study Start Date: February 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005816
Other Stage 4 Renal Cell Cancer Studies:
1. Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)
2. Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer
3. Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer
4. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
5. Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer
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