Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer

European Organisation for Research and Treatment of Cancer - EORTC44 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Cervical Cancer

Interventions

human papillomavirus 16 E7 peptideBIOLOGICAL

synthetic human papillomavirus 16 E6 peptideBIOLOGICAL

adjuvant therapyPROCEDURE

surgical procedure

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (10)

Innsbruck Universitaetsklinik

Innsbruck, Austria

Institut Curie - Section Medicale

Paris, France

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Germany

Outcomes

Primary Outcomes

Immunological response to HPV

Toxicity and safety of TA-HPV

Secondary Outcomes

Proliferative capacity of T-cells to the E6 and E7 proteins

Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence

Data from ClinicalTrials.gov

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