Vaccine Therapy in Treating Patients With Advanced Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00004880
First received: March 7, 2000
Last updated: July 27, 2012
Last verified: July 2012
  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 1

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:


Further study details as provided by Jonsson Comprehensive Cancer Center:

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
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Barbara J. Gitlitz, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
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: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Jonsson Comprehensive Cancer Center:
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 April 22, 2014