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Vaccine Therapy in Treating Patients With Advanced Kidney Cancer
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004880
  Purpose

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

MedlinePlus related topics: Cancer Kidney Cancer
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004880

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Barbara J. Gitlitz, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009