Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
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.
Biological: human papillomavirus 16 E7 peptide
Biological: synthetic human papillomavirus 16 E6 peptide
Procedure: adjuvant therapy
Procedure: surgical procedure
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|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|
- 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 ]
|Study Start Date:||November 1996|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002916
|Innsbruck, Austria, A-6020|
|Institut Curie - Section Medicale|
|Paris, France, 75248|
|Freiburg, Germany, D-79106|
|I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen|
|Munich, Germany, D-80337|
|Nijmegen Cancer Center at Radboud University Medical Center|
|Nijmegen, Netherlands, 6500|
|Norwegian Radium Hospital|
|Oslo, Norway, N-0310|
|University Hospital of Linkoping|
|Linkoping, Sweden, S-581 85|
|St. Mary's Hospital|
|Manchester, England, United Kingdom, M13 0JH|
|Ninewells Hospital and Medical School|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Velindre Cancer Center at Velinde Hospital|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|Study Chair:||Elaine M. Rankin, MD||Ninewells Hospital|