MedPath

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.

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
NameTimeMethod
Immunological response to HPV
Toxicity and safety of TA-HPV
Secondary Outcome Measures
NameTimeMethod
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

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