Phase II Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis (Residual Disease < 1cm) Associated With Ovarian Epithelial Cancer or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Rate of remission determined by laparoscopy or laparotomy
研究概览
简要总结
Phase II trial to study the effectiveness of intraperitoneal interleukin-12 in treating patients who have ovarian epithelial cancer or primary peritoneal cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Giving interleukin-12 directly into the peritoneal cavity may kill cancer cells
详细描述
OBJECTIVES:
I. Determine the response rate and progression-free interval in patients with peritoneal carcinomatosis associated with ovarian epithelial cancer or primary peritoneal carcinoma treated with intraperitoneal interleukin-12.
II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
III. Determine peritoneal cavity tumor cell responses, in terms of negative cytology, conversion of aneuploidy to diploidy, and apoptosis as evidence of therapeutic effect, in patients treated with this regimen.
IV. Assess quality of life in patients treated with this regimen. V. Determine the pharmacology and pharmacokinetics of this drug in these patients.
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
- 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
- •Histologically confirmed peritoneal carcinomatosis associated with ovarian epithelial or primary peritoneal epithelial carcinoma
- •Surgically documented disease after prior platinum-based chemotherapy with or without surgery
- •Minimal residual disease, defined as metastases less than 1 cm in largest diameter
- •No significant adhesions or symptoms of obstruction
- •No extra-abdominal or parenchymal disease
- •No more than 6 weeks since prior primary chemotherapy
- •Performance status - Zubrod 0-1
- •Absolute granulocyte count greater than 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Lymphocyte count greater than 600/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT or SGPT no greater than 2.5 times upper limit of normal
- •Albumin at least 3.0 g/dL
- •Hepatitis B and C negative
- •Creatinine no greater than 1.5 mg/dL
- •No significant cardiac disease
- •No significant pulmonary disease
- •No overt autoimmune disease
- •No other malignancy within the past 10 years except squamous cell carcinoma in situ or basal cell skin cancer
- •HIV negative
- •Successful placement of peritoneal catheter
- •No prior immunotherapy
- •See Disease Characteristics
- •Recovered from prior chemotherapy
- •No concurrent chemotherapy
- •No chronic steroid therapy
- •No prior radiotherapy
- •See Disease Characteristics
- •Recovered from prior surgery
- •At least 2 weeks since prior laparoscopy
- •At least 4 weeks since prior laparotomy
排除标准
- 未提供
结局指标
主要结局
Rate of remission determined by laparoscopy or laparotomy
时间窗: Up to 2 years
Tested using an exact test for a single binomial proportion
Toxicity graded using the NCI CTC version 3.0
时间窗: Up to 2 years
Evaluated for each dose level and each course of therapy.
Progression-free interval
时间窗: Up to 2 years
次要结局
未报告次要终点