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Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Vaccine Therapy in Treating Patients With Stage IV Renal Cell (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 IV Renal Cell (Kidney) Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer. Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer clinical trial. Subjects frequently get the best healthcare possible for their Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer  Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer
Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer
For Condition: recurrent renal cell cancer,stage 4 renal cell cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from a person's tumor cells combined with donor white blood cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effect of vaccine therapy on the body and its effectiveness in treating patients who have stage IV renal cell (kidney) cancer.
Details: OBJECTIVES: - Determine the safety of vaccination with allogeneic dendritic cells electrofused with autologous tumor cells in patients with stage IV renal cell carcinoma. - Determine the tumor response in patients treated with this vaccination. - Determine the immune response in patients treated with this vaccination. - Determine the overall survival and time to disease progression in patients treated with this vaccination. OUTLINE: This is an open-label, multicenter study. Patients undergo surgery to obtain tumor to create the vaccine product. Dendritic cells are prepared from donor blood. Within 6 weeks after surgery, patients are immunized with allogeneic dendritic cells electrofused with autologous tumor cells subcutaneously on days 0, 42, and 84 in the absence of unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A maximum of 40 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: - Diagnosis of renal cell carcinoma - Stage IV - Primary or relapsed disease - Previously received and failed 1 prior interleukin-2 therapy OR never received IL-2 therapy - Accessible tumor for vaccine production (at least 2.5 cm in diameter in aggregate) - Measurable tumor lesions remaining after resection of tumor used for vaccine production - Measurable disease must be outside any prior radiotherapy port or intratumoral treatment area (unless there is documented tumor progression after completion of the therapy) - No active or clinically significant CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - No clinically significant hematologic disease Hepatic - Bilirubin less than 2.0 mg/dL - AST and ALT less than 2.0 times upper limit of normal - No clinically significant hepatic disease Renal - Creatinine less than 2.0 mg/dL - No clinically significant renal disease Cardiovascular - No clinically significant cardiac disease Immunologic - HIV-1 and HIV-2 negative - HTLV-1 negative - No clinically significant autoimmune disorder - No active infection requiring parenteral antibiotics Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study treatment - No prior unrelated or second malignancy within the past 5 years except nonmelanoma skin cancer or in situ carcinomas - No underlying condition that would contraindicate study therapy or confuse interpretation of study results - No other reason, in the investigator's opinion, that would preclude study compliance or compromise ability to give informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - More than 30 days since prior nononcologic investigational biologic therapy - No other concurrent biologic therapy for malignancy Chemotherapy - No prior chemotherapy for renal cell carcinoma - No concurrent systemic chemotherapy for malignancy Endocrine therapy - No concurrent chronic oral steroid treatment Radiotherapy - See Disease Characteristics - More than 2 weeks since prior radiotherapy Surgery - Not specified Other - More than 2 weeks since prior treatment for renal cell carcinoma - More than 30 days since prior nononcologic investigational drugs or medical devices - No more than 2 prior regimens for the treatment of renal cell carcinoma - No other concurrent participation in studies utilizing investigational products - No concurrent chronic immunosuppressive treatment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertFiglin, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-5907
United States
Recruiting Robert Figlin 310-794-6501
Additional Information:
Study ID Numbers: CDR0000304541; GENZ-DCREN-005-01,UCLA-0209063
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062192
Other Stage 4 Renal Cell Cancer Studies:
1. Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer
2. Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation
3. Interleukin-2, Vinblastine, and GM-CSF in Treating Patients With Metastatic Kidney Cancer
4. AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
5. 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
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Vaccine Therapy in Treating Patients With Stage IV Renal Cell (Kidney) Cancer
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