Patient case: 26-year-old female with Cervical cancer. Genetic variant: STK11. Other conditions: None.

Clinical trial: Surgery and Vaccine Therapy in Treating Patients With Early 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.

Detailed 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.

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

Relevance to patient case: not relevant