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

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