Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 19 and over Other EORTC-13961 NCT00002916

Objectives

1. 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.
2. Investigate further the safety and toxic effects of TA-HPV in these patients.
3. Assess the proliferative capacity of T cells to the E6 and E7 proteins.
4. Observe any influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence in these patients.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

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

Expected Enrollment

44 patients will be entered over 1 year.

Outcomes

Immunological response to HPV
Toxicity and safety of TA-HPV

Proliferative capacity of T-cells to the E6 and E7 proteins
Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Elaine Rankin, MD, Protocol chair		Ph: 44-1382-425-543 Email: e.m.rankin@dundee.ac.uk

Registry Information
Official Title		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
Trial Start Date		1996-11-01
Registered in ClinicalTrials.gov		NCT00002916
Date Submitted to PDQ		1996-11-01
Information Last Verified		2006-01-05

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