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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Advanced Kidney Cancer  Vaccine Therapy in Treating Patients With Advanced Kidney Cancer
Vaccine Therapy in Treating Patients With Advanced Kidney Cancer
For Condition: stage 4 renal cell cancer,recurrent renal cell cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson 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 advanced kidney cancer.
Details: OBJECTIVES: I. Evaluate the safety of multiantigen loaded dendritic cells (DC) vaccine in patients with advanced renal cell carcinoma. II. Evaluate the immunologic response to this regimen in this patient population. III. Evaluate the clinical response to this regimen in this patient population. PROTOCOL OUTLINE: This is a sequential cohort study. All patients undergo total nephrectomy to harvest primary tumor for vaccine preparation. Patients without primary tumor undergo surgical resection of the accessible metastatic site for vaccine preparation. Patients are assigned to 1 of 4 treatment arms. Arm I: Patients receive vaccination with irradiated autologous tumor lysate (TuLy) intradermally (ID) on day 0 followed by vaccination with multiantigen liposome loaded dendritic cells (DC) ID on days 7, 14, and 21. Arm II: Patients receive vaccinations as in arm I, except DC are pulsed with tumor cells. Arm III: Patients receive vaccination with irradiated autologous tumor lysate (TuLy) IV on day 0 followed by vaccination with multiantigen liposome loaded DC IV on days 7, 14, and 21. Arm IV: Patients receive vaccinations as in arm III, except DC are treated as in arm II. Patients are followed on days 28, 42, 70, and 112. PROJECTED ACCRUAL: A total of 24 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 confirmed metastatic renal cell carcinoma - Evaluable or bidimensionally measurable disease with primary renal tumor in place or surgically accessible metastatic site greater than 2 x 2 cm - No uncontrolled CNS metastasis --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy - Chemotherapy: At least 4 weeks since prior chemotherapy - Endocrine therapy: No concurrent corticosteroids (oral, topical, inhaled) - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: See Disease Characteristics; No prior organ allografts - Other: At least 14 days since prior acute therapy for infection --Patient Characteristics-- - Age: Over 18 - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: Hemoglobin at least 10 g/dL (not transfusion dependent); Platelet count at least 75,000/mm3; WBC greater than 3,000/mm3 - Hepatic: SGOT/SGPT no greater than 5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 5 times ULN; PT/PTT no greater than 1.5 times ULN; Bilirubin no greater than 2.5 mg/dL - Renal: Creatinine no greater than 2.0 g/dL - Cardiovascular: No ischemic heart disease that precludes surgery - Pulmonary: No pulmonary condition that precludes surgery - Other: Hepatitis B surface antigen negative; No other underlying condition or allergy that would preclude study; No acute viral, bacterial, or fungal infection requiring therapy; HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other acute medical problems that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BarbaraGitlitz, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000067542; UCLA-9703025,NCI-G00-1675
Study Start Date: December 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004880
Other Recurrent Renal Cell Cancer Studies:
1. UCN-01 in Treating Patients With Advanced or Metastatic Kidney Cancer
2. Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
3. Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
4. Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer
5. Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer
Related Studies:
Other recurrent renal cell cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Vaccine Therapy in Treating Patients With Advanced Kidney Cancer
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