Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-h.B7.1 Plus IP rIFN-gamma for Patients With Ovarian Cancer. A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Autologous tumor cell cytotoxicity lymphocyte (CTL)
研究概览
简要总结
Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer. Vaccines made from a person's cancer cells may make the body build an immune response to and kill their tumor cells. Combining vaccine therapy with interferon gamma may be a more effective treatment for epithelial ovarian cancer
详细描述
OBJECTIVES:
I. Determine whether intraperitoneal (IP) injections of epithelial ovarian carcinoma cells infected with ALVAC-hB7.1 and IP interferon gamma have acceptable toxicity and produce any clinical responses in patients with refractory ovarian epithelial cancer.
OUTLINE: This is a dose-escalation study of ALVAC-hB7.1 infected tumor cells.
Patients receive ALVAC-hB7.1 infected tumor cells intraperitoneally (IP) on days 4, 11, and 18. Patients also receive interferon gamma IP on days 8, 10, 15, and 17. In the absence of disease progression, up to 6 courses of therapy may be given. If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine, interferon gamma may be given alone. Cohorts of 3 to 6 patients receive escalating doses of ALVAC-hB7.1 infected tumor cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 6 months until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ovarian epithelial carcinoma
- •Previously treated with an adequate course of platinum based chemotherapy
- •Evidence of intraabdominal disease
- •No significant adhesions
- •Performance status - Zubrod 0-2
- •Lymphocyte count at least 500/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT less than 2.5 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL
- •No major disorder of the cardiovascular system
- •No major disorder of the pulmonary system
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Successful placement of peritoneal catheter
- •No overt autoimmune disease
- •No concurrent chronic steroid therapy
- •No prior radiotherapy
- •Prior surgery allowed
- •Recovered from prior therapy
排除标准
- 未提供
结局指标
主要结局
Autologous tumor cell cytotoxicity lymphocyte (CTL)
时间窗: Up to 7 years
Cytokine production (IFN gamma, IL-10, IL-2) by RT-PCR
时间窗: Up to 7 years
Toxicity as assessed by NCI Common Terminology Criteria (CTC)
时间窗: 3 weeks
次要结局
未报告次要终点