Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
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
  • Phase

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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.

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 Started
Nov 30
Last Update
Jul 02

Biological human papillomavirus 16 E7 peptide

Biological synthetic human papillomavirus 16 E6 peptide

Procedure adjuvant therapy

Procedure surgical procedure

Radiation radiation therapy



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



19 and over

Performance status:

WHO/ECOG no greater than 2

Life expectancy:

At least 3 months


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


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


Creatinine less than 1.3 mg/dL (120 micromoles/L)


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
Children under 5 years old


Biologic therapy:

Not specified


Not specified

Endocrine therapy:

Not specified


Not specified


Not specified
No Results Posted