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Vaccine Therapy in Treating Patients With Advanced Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004880
Recruitment Status : Completed
First Posted : May 20, 2004
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Kidney Cancer Biological: dendritic cell vaccine therapy Procedure: conventional surgery Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : June 1997
Actual Primary Completion Date : April 2001

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004880


Locations
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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Study Chair: Barbara J. Gitlitz, MD Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00004880    
Other Study ID Numbers: CDR0000067542
UCLA-9703025
NCI-G00-1675
First Posted: May 20, 2004    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2012
Keywords provided by Jonsson Comprehensive Cancer Center:
stage IV renal cell cancer
recurrent renal cell cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
 Urologic Diseases
Male Urogenital Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vaccines
Immunologic Factors
Physiological Effects of Drugs