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Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer
This study is ongoing, but not recruiting participants.
First Received: March 8, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031564
  Purpose

RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer.


Condition Intervention Phase
Kidney Cancer
Biological: adenovirus B7-1
Biological: aldesleukin
Biological: autologous tumor cell vaccine
Procedure: conventional surgery
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2 for Patients With Stage IV Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
Detailed Description:

OBJECTIVES:

  • Determine the percentage of patients with stage IV renal cell carcinoma with a reduction in tumor size after treatment with B7-1 gene-modified autologous tumor cell vaccine and interleukin-2.
  • Determine the immunogenicity of this regimen in these patients.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the local and systemic toxicity of this regimen in these patients.

OUTLINE: Tumor tissue for vaccine preparation is obtained when patients undergo palliative surgical resection of primary tumor or therapeutic resection of metastasis.

At approximately 3-6 weeks after surgery, patients receive B7-1 gene-modified autologous tumor cell vaccine subcutaneously (SC) once on days 1, 29, and 57. At 6 weeks after the first vaccination, patients receive interleukin-2 (IL-2) SC five days a week for 6 weeks (days 43-82). Patients with stable or responding disease after day 106 may receive additional vaccinations in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks after the last dose of IL-2.

PROJECTED ACCRUAL: Approximately 30 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

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV renal cell carcinoma

    • Symptomatic primary tumor or resectable metastasis
  • Measurable disease post resection
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 10 g/dL
  • Hematocrit greater than 30%

Hepatic:

  • Bilirubin less than 2 times normal
  • SGOT less than 3 times normal

Renal:

  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • No evidence of active myocardial ischemia, prior myocardial infarction, or arrhythmia

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No contraindications to surgical resection
  • No history of immunodeficiency disease
  • No known allergy to penicillin

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior interleukin-2, interferon alfa, or other biologic agent allowed

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No concurrent corticosteroids (except for replacement doses for adrenal insufficiency)

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent immunosuppressants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031564

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Study Chair: Scott J. Antonia, MD, PhD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068260, MCC-12207, MCC-IRB-5620, NCI-5090, NCI-G00-1872
Study First Received: March 8, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00031564     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Antineoplastic Agents
Urogenital Neoplasms
Urologic Neoplasms
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Aldesleukin
Anti-Retroviral Agents
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009