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Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002916
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):
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.

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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
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
Study Start Date : November 1996

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Primary Outcome Measures :
  1. Immunological response to HPV
  2. Toxicity and safety of TA-HPV

Secondary Outcome Measures :
  1. Proliferative capacity of T-cells to the E6 and E7 proteins
  2. Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically proven untreated stage Ib or IIa cervical carcinoma, squamous or adenocarcinoma suitable for surgical excision

    • No CNS metastases
  • Circulating CD4+ lymphocyte count at least 400
  • Proven absence of hepatitis B and C antibodies
  • Previous exposure to vaccinia from smallpox vaccination, as well as no previous exposure, is allowed
  • Reaction to 2 or more antigens on Pasteur Merieux CMI test required
  • Ability to collaborate planned follow-up required



  • 19 and over

Performance status:

  • WHO/ECOG no greater than 2

Life expectancy:

  • At least 3 months


  • WBC greater than 3,000 (3,000 x 10 to the ninth/L)
  • Platelet count greater than 120,000 (120 x 10 to the ninth/L)
  • No bleeding disorder


  • Bilirubin less than 1.5 times normal
  • AST and ALT less than 1.5 times normal
  • Prothrombin or partial thromboplastin time no greater than 2 times normal


  • Creatinine less than 1.3 mg/dL (120 micromoles/L)


  • No ongoing infection
  • No HIV antibody
  • No serious medical or psychiatric illness
  • No second malignancy within 5 years except for curatively treated basal cell skin cancer which required surgery, hormone therapy, immunotherapy or chemotherapy
  • Not pregnant or nursing
  • Adequate contraception required
  • Patient or her household contacts must not have any of the following:

    • Chronic steroid therapy
    • Renal or other allograft
    • Known immunodeficiency
    • Eczema
    • Children under 5 years old


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

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 identifier (NCT number): NCT00002916

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Innsbruck Universitaetsklinik
Innsbruck, Austria, A-6020
Institut Curie - Section Medicale
Paris, France, 75248
Universitaetsklinikum Freiburg
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
United Kingdom
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
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Elaine M. Rankin, MD Ninewells Hospital

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00002916     History of Changes
Other Study ID Numbers: EORTC-13961
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IB cervical cancer
stage IIA cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female