A Phase II Trial in Patients With Early Cervical Cancer to Study The Safety and The Immunological Effects of Vaccination With TA-HPV, A Live Recombinant Vaccinia Virus Expressing The Human Papilloma Virus 16 and 18 E6 and E7 Proteins
- 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
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
PROJECTED ACCRUAL: 44 patients will be entered over 1 year.
Primary Purpose: Treatment
Immunological response to HPV
Elaine M. Rankin, MD
United States: Federal Government