Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Elaine M. Rankin

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002916
Information obtained from ClinicalTrials.gov on December 19, 2011

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