Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer

• Immunological response to HPV [ Designated as safety issue: No ]
  
• Toxicity and safety of TA-HPV [ Designated as safety issue: Yes ]
  

• Proliferative capacity of T-cells to the E6 and E7 proteins [ Designated as safety issue: No ]
  
• Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence [ Designated as safety issue: No ]
  

OBJECTIVES:

• Evaluate the systemic immunological response to the human papilloma virus vaccine (TA-HPV) expressing the proteins 16, 18, E6 and E7 examining the cytolytic T cell and the antibody responses in cervical cancer patients.
• Investigate further the safety and toxic effects of TA-HPV in these patients.
• Assess the proliferative capacity of T cells to the E6 and E7 proteins.
• Observe any influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence in these patients.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive 2 vaccinations of the human papilloma virus with proteins 16, 18, E6 and E7 at least 4 weeks apart, with the first vaccination at least 2 weeks before surgery and the second 8 weeks after the first one, unless unacceptable toxicity occurs. Patients who require radiotherapy following surgery receive their second vaccination 4-8 weeks after the first vaccination.

Twenty-eight patients are entered initially; if at least 2 patients show an immunologic response, 16 additional patients are entered.

Patients are followed every 3 months for 2 years, then every 6 months for 3 years, then annually.

PROJECTED ACCRUAL: 44 patients will be entered over 1 year.