Cervical Cancer Clinical Trial
Official title:
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
RATIONALE: Vaccines made from human papillomavirus may make the body build an immune
response to and kill cervical cancer cells. Combining vaccine therapy with surgery may be a
more effective treatment for cervical cancer.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with
surgery works in treating patients with early cervical cancer.
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.
;
Primary Purpose: Treatment
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