Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
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
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||November 1999|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003977
|United States, Massachusetts|
|St. Elizabeth's Medical Center|
|Boston, Massachusetts, United States, 02135-2997|
|Study Chair:||Michael A. Steller, MD||Steward St. Elizabeth's Medical Center of Boston, Inc.|