surgery and vaccine therapy in treating patients with early cervical cancer

Conditions: Cervical Cancer

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.

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.

Eligibility 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

Keywords: stage ib cervical cancer stage iia cervical cancer cervical squamous cell carcinoma cervical adenocarcinoma cervical adenosquamous cell carcinoma