Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer - Full Text View

Sponsor:	European Organization for Research and Treatment of Cancer - EORTC
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002916

Purpose

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	Intervention	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 II

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Immunological response to HPV [ Designated as safety issue: No ]
Toxicity and safety of TA-HPV [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	44
Study Start Date:	November 1996

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

19 and over

Performance status:

WHO/ECOG no greater than 2

Life expectancy:

At least 3 months

Hematopoietic:

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

Hepatic:

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

Renal:

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

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002916

Locations

Austria
Innsbruck Universitaetsklinik
Innsbruck, Austria, A-6020
France
Institut Curie - Section Medicale
Paris, France, 75248
Germany
Universitaetsklinikum Freiburg
Freiburg, Germany, D-79106
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
Munich, Germany, D-80337
Netherlands
Nijmegen Cancer Center at Radboud University Medical Center
Nijmegen, Netherlands, 6500
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Sweden
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 Organization for Research and Treatment of Cancer - EORTC

Investigators

Study Chair:

Elaine M. Rankin, MD

Ninewells Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00002916 History of Changes
Other Study ID Numbers:	CDR0000065295, EORTC-13961
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IB cervical cancer
stage IIA cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Vaccinia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms

Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 12, 2012