Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002916
• Other study ID #: EORTC-13961
• Secondary ID: EORTC-13961
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 29, 2012
• Start date: November 1996

Study information

• Verified date: June 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Biological:
• human papillomavirus 16 E7 peptide

• synthetic human papillomavirus 16 E6 peptide

Procedure:
• adjuvant therapy

• surgical procedure

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Austria	Innsbruck Universitaetsklinik	Innsbruck
France	Institut Curie - Section Medicale	Paris
Germany	Universitaetsklinikum Freiburg	Freiburg
Germany	I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen	Munich
Netherlands	Nijmegen Cancer Center at Radboud University Medical Center	Nijmegen
Norway	Norwegian Radium Hospital	Oslo
Sweden	University Hospital of Linkoping	Linkoping
United Kingdom	Velindre Cancer Center at Velinde Hospital	Cardiff	Wales
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	St. Mary's Hospital	Manchester	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunological response to HPV			No
Primary	Toxicity and safety of TA-HPV			Yes
Secondary	Proliferative capacity of T-cells to the E6 and E7 proteins			No
Secondary	Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence			No