Vaccine Therapy in Treating Patients With Advanced Kidney Cancer

July 30, 2020 updated by: Jonsson Comprehensive Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Study Chair: Barbara J. Gitlitz, MD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1997

Primary Completion (Actual)

April 1, 2001

Study Registration Dates

First Submitted

March 7, 2000

First Submitted That Met QC Criteria

May 19, 2004

First Posted (Estimate)

May 20, 2004

Study Record Updates

Last Update Posted (Actual)

August 3, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067542
  • UCLA-9703025
  • NCI-G00-1675

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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