NCT00002916

Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	human papillomavirus 16 E7 peptide
BIOLOGICAL	synthetic human papillomavirus 16 E6 peptide
PROCEDURE	adjuvant therapy
PROCEDURE	surgical procedure
RADIATION	radiation therapy

Timeline

• Start date: 1996-11-01
• First posted: 2003-01-27
• Last updated: 2012-07-02

Locations

10 sites across 7 countries: Austria, France, Germany, Netherlands, Norway, Sweden, United Kingdom