Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
- Conditions
- Cervical Cancer
- Registration Number
- NCT00002916
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 44
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunological response to HPV Toxicity and safety of TA-HPV
- Secondary Outcome Measures
Name Time Method Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence Proliferative capacity of T-cells to the E6 and E7 proteins
Trial Locations
- Locations (10)
Innsbruck Universitaetsklinik
🇦🇹Innsbruck, Austria
Institut Curie - Section Medicale
🇫🇷Paris, France
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
🇩🇪Munich, Germany
Nijmegen Cancer Center at Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
Norwegian Radium Hospital
🇳🇴Oslo, Norway
University Hospital of Linkoping
🇸🇪Linkoping, Sweden
St. Mary's Hospital
🇬🇧Manchester, England, United Kingdom
Ninewells Hospital and Medical School
🇬🇧Dundee, Scotland, United Kingdom
Velindre Cancer Center at Velinde Hospital
🇬🇧Cardiff, Wales, United Kingdom
Innsbruck Universitaetsklinik🇦🇹Innsbruck, Austria