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Vaccine Therapy in Treating Patients With Advanced Kidney Cancer
This study is ongoing, but not recruiting participants.
Study NCT00004880   Information provided by National Cancer Institute (NCI)
First Received: March 7, 2000   Last Updated: February 6, 2009   History of Changes

March 7, 2000
February 6, 2009
December 2000
 
 
 
Complete list of historical versions of study NCT00004880 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy in Treating Patients With Advanced Kidney Cancer
A Phase I Pilot Trial of a Multi-Antigen Loaded Dendritic Cell Vaccine for the Treatment of Advanced Renal Cell Carcinoma

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.

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.

Phase I
Interventional
Treatment
Kidney Cancer
  • Biological: dendritic cell vaccine therapy
  • Procedure: conventional surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004880
 
CDR0000067542, UCLA-9703025, NCI-G00-1675
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Barbara J. Gitlitz, MD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP