Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer

Phase 2

Completed

• Conditions: Cervical Cancer

• Registration Number: NCT00002916
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study Start: 1996-11
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

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