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A Phase I Study of Immunization With Alternating Human Papillomavirus E7 Lipopeptide Epitope Vaccine and Dendritic Cells Presenting the E7 Epitope for the Treatment of Recurrent or Persistent Cervical Cancer (NCT00003977)

National Cancer Institute (NCI)
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 with recurrent or persistent cervical cancer that cannot be treated with surgery or radiation therapy.
  • Biological: human papillomavirus 16 E7 peptide
    • Procedure: in vitro-treated peripheral blood stem cell transplantation
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      Female
      Accepts Healthy Volunteers
      No
      OBJECTIVES:

      - Evaluate alternating vaccination with lipidated human papillomavirus 16 E7 peptide (HPV-16 E7) and autologous dendritic cells pulsed with immunogenic HPV-16 E7 in terms of toxicity, immunologic reactivity, and therapeutic efficacy in patients with recurrent or persistent cervical cancer.

      OUTLINE: This is a dose-escalation study of dendritic cell-human papillomavirus 16 E7 (HPV-16 E7) peptide vaccine.

      Patients undergo leukapheresis to obtain peripheral blood mononuclear cells for activation to dendritic cells on days 0 and 28. Patients receive lipidated HPV-16 E7 peptide vaccine subcutaneously on days 1 and 14 and dendritic cell-HPV-16 E7 peptide vaccine IV over 15-30 minutes on days 7 and 21. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable disease or complete or partial response may receive one additional treatment course, beginning 6 weeks after the end of the first course.

      Cohorts of 3-9 patients receive escalating doses of dendritic cell-HPV-16 E7 peptide vaccine. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

      A parallel cohort of patients receives dendritic cell-HPV-16 E7 peptide vaccine IV over 15-30 minutes on days 7 and 14, but does not receive lipidated HPV-16 E7 peptide.

      Patients are followed at one week.

      PROJECTED ACCRUAL: Approximately 27 patients will be accrued for this study at a rate of 15 patients per year.

      1 locations

      United States (1)
      • St. Elizabeth's Medical Center
        Not specified
        Boston, Massachusetts, United States, 02135-2997
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      31 October, 1999
      Updated:
      05 February, 2009
      Participants:
      0
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