Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00002916|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 2, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Biological: human papillomavirus 16 E7 peptide Biological: synthetic human papillomavirus 16 E6 peptide Procedure: adjuvant therapy Procedure: surgical procedure Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|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|
|Study Start Date :||November 1996|
- Immunological response to HPV
- Toxicity and safety of TA-HPV
- Proliferative capacity of T-cells to the E6 and E7 proteins
- Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|