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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004880 |
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.
Condition | Intervention | Phase |
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Kidney Cancer |
Biological: dendritic cell vaccine therapy Procedure: conventional surgery |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Pilot Trial of a Multi-Antigen Loaded Dendritic Cell Vaccine for the Treatment of Advanced Renal Cell Carcinoma |
Study Start Date: | December 2000 |
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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
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
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 |
Study Chair: | Barbara J. Gitlitz, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067542, UCLA-9703025, NCI-G00-1675 |
Study First Received: | March 7, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004880 History of Changes |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer recurrent renal cell cancer |
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Recurrence Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell |
Urogenital Neoplasms Kidney Diseases Urologic Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |