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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 2
19 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Immunological response to HPV

Safety Issue:

No

Principal Investigator

Elaine M. Rankin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ninewells Hospital

Authority:

United States: Federal Government

Study ID:

EORTC-13961

NCT ID:

NCT00002916

Start Date:

November 1996

Completion Date:

Related Keywords:

  • Cervical Cancer
  • stage IB cervical cancer
  • stage IIA cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • Uterine Cervical Neoplasms
  • Vaccinia

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