A Phase I Dose-Escalating Study of Recombinant Human Interleukin-12 (NSC # 672423) Administered by Intraperitoneal Infusion in Refractory Advanced Stage Ovarian Cancer and Other Abdominal Carcinomatosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
Phase I trial to study the effectiveness of interleukin-12 in treating patients with refractory ovarian or abdominal cancers. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons's white blood cells to kill cancer cells.
详细描述
OBJECTIVES:
I. Assess the safety and maximum tolerated dose of recombinant human interleukin-12 (rhIL-12) administered by intraperitoneal infusion in patients with chemotherapy refractory advanced ovarian cancer and other diffuse abdominal carcinomatosis.
II. Determine the immunopharmacologic profile of rhIL-12 in this patient population.
III. Evaluate the biologic response in selected patients to rhIL-12 administered through intraperitoneal infusions.
OUTLINE: This is a dose escalation, multicenter study.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed intraabdominal cancer
- •Diffuse abdominal carcinomatosis Chemotherapy refractory advanced stage ovarian cancer
- •Measurable disease
- •Residual, recurrent, or metastatic disease beyond the scope of standard curative therapy
- •Extension of disease to sites distant to the peritoneal cavity allowed Retroperitoneal lymphadenopathy allowed as long as there is evaluable intraabdominal disease
- •No history of progressive brain metastases
- •PATIENT CHARACTERISTICS:
- •Age: 18 and over
- •Performance status: Karnofsky 70-100%
- •Hemoglobin greater than 9 g/dL
- •WBC greater than 3,000/mm3
- •Platelet count greater than 100,000/mm3
- •Bilirubin less than 2.0 mg/dL
- •ALT less than 100 U/L
- •Creatinine clearance greater than 60 mL/min
- •Normal electrocardiogram
- •No recent history of cardiac ischemia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Hepatitis B negative
- •No evidence of clinical immunodeficiency syndromes or immunodeficiency associated diseases
- •No history of autoimmune disease
- •No concurrent major illness
- •No serious infection requiring intravenous antibiotics
- •No active peptic ulcer disease
- •Must have free flow of fluid into the peritoneal space
- •No leakage from the catheter exit site
- •PRIOR CONCURRENT THERAPY:
- •At least 3 weeks since prior biologic therapy (6 weeks for interleukin-2)
- •No prior recombinant human interleukin-12
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •No concurrent systemic chemotherapy
- •No concurrent systemic corticosteroids
- •No prior radiation therapy to the whole abdomen
- •No concurrent radiotherapy
- •At least 3 weeks since prior exposure to any investigational drug
- •No concurrent investigational drug
排除标准
- 未提供
研究组 & 干预措施
Arm I
Cohorts of 3-6 patients each receive escalating doses of intraperitoneal recombinant human interleukin-12 (rhIL-12) administered weekly for 9 weeks. If a patient tolerates rhIL-12 and shows evidence of objective response or stable disease, patient may receive up to 9 additional weeks of treatment. Treatment continues in the absence of unacceptable toxicity or disease progression. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which no more than 1 of 6 patients experiences dose limiting toxicity.
干预措施: recombinant interleukin-12 (Biological)