Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 2

Conditions: Cervical Cancer

Treatments: Procedure: surgical procedure; Biological: human papillomavirus 16 E7 peptide; Radiation: radiation therapy; Biological: synthetic human papillomavirus 16 E6 peptide; Procedure: adjuvant therapy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00002916

EORTC-13961

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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