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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 10
- 主要终点
- Immunological response to HPV
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •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
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Immunological response to HPV
Toxicity and safety of TA-HPV
次要结局
- Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence
- Proliferative capacity of T-cells to the E6 and E7 proteins