Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer

NCT ID: NCT00002916

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-11-30

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.

Conditions

Cervical Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

human papillomavirus 16 E7 peptide

Intervention Type: BIOLOGICAL

synthetic human papillomavirus 16 E6 peptide

Intervention Type: BIOLOGICAL

adjuvant therapy

Intervention Type: PROCEDURE

surgical procedure

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elaine M. Rankin, MD

Role: STUDY_CHAIR

Ninewells Hospital

Locations

Innsbruck Universitaetsklinik

Innsbruck, , Austria

Institut Curie - Section Medicale

Paris, , France

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , 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

Linköping, , 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

Countries

Austria; France; Germany; Netherlands; Norway; Sweden; United Kingdom

Other Identifiers

EORTC-13961

Identifier Type: -

Identifier Source: secondary_id

EORTC-13961

Identifier Type: -

Identifier Source: org_study_id