Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer

March 19, 2013 updated by: Duke University

Active Immunotherapy of Metastatic Renal Cell Carcinoma Using Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA

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 stage III or stage IV kidney cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of autologous dendritic cells transfected with autologous total tumor RNA in patients with stage III or IV renal cell carcinoma. II. Assess the toxicity and feasibility of this treatment regimen in these patients. III. Evaluate this regimen in terms of cellular immune response, clinical response, and overall survival in these patients.

OUTLINE: This is a dose-escalation study. Patients undergo nephrectomy for tumor RNA extraction followed by leukapheresis to collect peripheral blood mononuclear cells for dendritic cell (DC) production. Patients receive autologous DC transfected with autologous renal cell carcinoma RNA both IV and intradermally on weeks 0, 2, and 4. Cohorts of 3-6 patients receive escalating doses of DC IV until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study over 24 months.

Study Type

Interventional

Enrollment (Actual)

15

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
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center

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

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV renal cell carcinoma scheduled for resection of primary renal tumor No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 6 months Hematopoietic: WBC at least 3,000/mm3 Hemoglobin at least 9 mg/dL (transfusion independent) Platelet count at least 100,000/mm3 No history of bleeding disorder or other blood dyscrasias Hepatic: Bilirubin less than 2.0 mg/dL PT less than 1.5 times control No serious hepatic disease Renal: Creatinine no greater than 2.5 mg/dL Calcium less than 12 mg/dL No symptomatic hypercalcemia Cardiovascular: No serious cardiac disease (e.g., New York Heart Association class III or IV heart disease) No deep vein thrombosis Pulmonary: No serious pulmonary disease (e.g., asthma or chronic obstructive pulmonary disease) No pulmonary embolism Other: No serious chronic or acute illness that would preclude study No autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis) No psychological impediment that would preclude study No prior malignancy within past 5 years except basal cell carcinoma, carcinoma in situ of the cervix, nonmelanomatous skin cancer, controlled superficial bladder cancer, or surgically or radiologically treated prostatic adenocarcinoma with no evidence of rising PSA for at least 12 months after treatment No active acute or chronic infection (e.g., symptomatic urinary tract infection, surgical site infection, or viral hepatitis) HIV negative Must have adequate peripheral vein access Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy (e.g., interleukin-2, interferon alfa, or autolymphocyte therapy) No other concurrent immunotherapy Chemotherapy: At least 6 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: At least 6 weeks since prior steroid therapy and recovered No concurrent steroid therapy Radiotherapy: At least 6 weeks since prior radiotherapy and recovered No concurrent local or palliative radiotherapy Surgery: See Disease Characteristics At least 6 weeks since other prior major surgery and recovered No prior radical nephrectomy Other: No concurrent immunosuppressive agents (e.g., azathioprine or cyclosporine)

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

Duke University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Johannes Vieweg, MD, Duke Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2000

Study Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

March 22, 2004

First Posted (Estimate)

March 23, 2004

Study Record Updates

Last Update Posted (Estimate)

March 20, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1716
  • DUMC-1862-99-10
  • DUMC-DORIS-99124
  • DUMC-GCRC-839
  • NCI-G00-1787
  • CDR0000067820 (Other Identifier: NCI)
  • 1R01CA089102-01 (U.S. NIH Grant/Contract)

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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