Phase I Clinical Trials of IV rhIL-12 With or Without a Test-Dose in Patients With Advanced Malignancies (rhIL-12 NSC# 672423)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 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 who have advanced 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 cancer cells.
详细描述
OBJECTIVES:
I. Determine the toxicity profile and maximum tolerated dose (MTD) of intravenous interleukin-12 (IL-12) administered biweekly for 6-18 weeks in the presence and absence of a test dose in patients with metastatic or unresectable malignancies.
II. Determine the optimal timing for administration of an IL-12 test dose, based on its impact on secondary biologic parameters in these patients.
III. Determine the antitumor effects of IL-12 administered according to this schedule, with and without a test dose, in these patients.
IV. Determine the effect of a test dose on toxicity profile, MTD, tumor response and various biologic phenomena in serum, and, where possible, tumor and liver 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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- •Advanced measurable or evaluable disease that is clearly progressive
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •Age: 18 and over
- •Performance status: ECOG 0-1 Karnofsky 80-100%
- •Life expectancy: At least 3 months
- •WBC greater than 4,000/mm3
- •Platelet count greater than 100,000/mm3
- •Bilirubin less than 1.5 mg/dL
- •SGOT/SGPT less than 2 times normal
- •Creatinine less than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •No congestive heart failure
- •No coronary artery disease
- •No serious cardiac arrhythmias
- •No evidence of prior myocardial infarction on EKG
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Not HIV positive
- •No seizure disorders
- •No active infection that requires antibiotic therapy
- •No significant medical disease other than the malignancy
- •PRIOR CONCURRENT THERAPY:
- •No more than 2 prior biological response modifier treatment regimen
- •No immunotherapy within the past 4 weeks
- •No prior interleukin-12
- •No more than 2 prior chemotherapy regimens
- •At least 4 weeks since chemotherapy and recovered
- •At least 6 weeks since nitrosoureas or mitomycin and recovered
- •No concurrent chemotherapy
- •At least 4 weeks since hormone therapy and recovered
- •No concurrent hormone therapy
- •No concurrent corticosteroids
- •At least 4 weeks since radiotherapy and recovered
- •No concurrent radiotherapy
- •No organ allografts
- •At least 2 weeks since intravenous antibiotics
排除标准
- 未提供
研究组 & 干预措施
Arm I
See detailed description.
干预措施: recombinant interleukin-12 (Biological)