Vaccine Therapy in Treating Patients With Advanced Kidney Cancer - Full Text View

Sponsor:	University of California, Los Angeles
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
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

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase I Pilot Trial of a Multi-Antigen Loaded Dendritic Cell Vaccine for the Treatment of Advanced Renal Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Enrollment:	14
Study Start Date:	June 1997
Primary Completion Date:	April 2001 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

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
Over 18
ECOG 0-1
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
Hepatitis B surface antigen negative
Negative pregnancy test
Fertile patients must use effective contraception
At least 4 weeks since prior immunotherapy
At least 4 weeks since prior chemotherapy
At least 4 weeks since prior radiotherapy
At least 14 days since prior acute therapy for infection

Exclusion Criteria:

uncontrolled CNS metastasis
ischemic heart disease that precludes surgery
pulmonary condition that precludes surgery
other underlying condition or allergy that would preclude study
acute viral, bacterial, or fungal infection requiring therapy HIV negative
pregnant or nursing
other acute medical problems that would preclude study
concurrent corticosteroids (oral, topical, inhaled)
prior organ allografts

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

University of California, Los Angeles

National Cancer Institute (NCI)

Investigators

Study Chair:

Barbara J. Gitlitz, MD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Barbara Gitlitz, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00004880 History of Changes
Other Study ID Numbers:	CDR0000067542, P30CA016042, UCLA-9703025, NCI-G00-1675
Study First Received:	March 7, 2000
Last Updated:	June 16, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:

Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 12, 2012