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
- 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
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.
Primary Purpose: Treatment
Michael A. Steller, MD
Steward St. Elizabeth's Medical Center of Boston, Inc.
United States: Federal Government
|St. Elizabeth's Medical Center||Boston, Massachusetts 02135-2997|