A Phase I Study of Immunization With Alternating Human Papillomavirus E7 Lipopeptide Epitope Vaccine and Dendritic Cells Presenting the E7 Epitope for the Treatment of Recurrent or Persistent Cervical Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients with recurrent or persistent cervical cancer that cannot be treated with surgery or radiation therapy.
详细描述
OBJECTIVES:
- Evaluate alternating vaccination with lipidated human papillomavirus 16 E7 peptide (HPV-16 E7) and autologous dendritic cells pulsed with immunogenic HPV-16 E7 in terms of toxicity, immunologic reactivity, and therapeutic efficacy in patients with recurrent or persistent cervical cancer.
OUTLINE: This is a dose-escalation study of dendritic cell-human papillomavirus 16 E7 (HPV-16 E7) peptide vaccine.
Patients undergo leukapheresis to obtain peripheral blood mononuclear cells for activation to dendritic cells on days 0 and 28. Patients receive lipidated HPV-16 E7 peptide vaccine subcutaneously on days 1 and 14 and dendritic cell-HPV-16 E7 peptide vaccine IV over 15-30 minutes on days 7 and 21. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable disease or complete or partial response may receive one additional treatment course, beginning 6 weeks after the end of the first course.
Cohorts of 3-9 patients receive escalating doses of dendritic cell-HPV-16 E7 peptide vaccine. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven recurrent or persistent cervical cancer not amenable to surgery or radiotherapy
- •Measurable and evaluable disease
- •HLA-A2 positive
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 8.0 g/dL
- •No coagulation disorders
- •Bilirubin less than 2.0 mg/dL
- •SGOT less than 4 times upper limit of normal
- •Creatinine less than 1.5 mg/dL OR
- •Creatinine clearance greater than 75 mL/min
- •Cardiovascular:
- •No major cardiovascular illness
- •No major pulmonary illness
- •HIV negative
- •Hepatitis B surface antigen negative
- •No active systemic infection
- •Not pregnant
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least one month since prior biologic therapy
- •Chemotherapy:
- •At least one month since prior chemotherapy
- •Endocrine therapy:
- •At least one month since prior endocrine therapy
- •No concurrent steroid therapy
- •Radiotherapy:
- •See Disease Characteristics
- •At least one month since prior radiotherapy
- •See Disease Characteristics
- •At least one month since prior surgery
排除标准
- 未提供