A Phase I Study Of The Toxicities, Biologic And Clinical Effects Of Daily 5 Aza 2'Deoxycytidine (DAC), NSC 127716 (IND 50733) For Four Weeks In Patients With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria
研究概览
简要总结
This phase I trial is studying the side effects and best dose of decitabine in treating patients with advanced solid tumors that have not responded to previous treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
详细描述
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors.
II. Determine the toxic effects of this drug in these patients. III. Determine the dose of this drug with biologic activity in these patients. IV. Determine the pharmacokinetics of this drug in these patients. V. Determine clinical response to this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
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
- •Diagnosis of advanced metastatic solid tumor for which all standard therapy has failed, including, but not limited to the following:
- •Stage III or IV melanoma
- •Mucosal melanoma allowed
- •No resectable stage III melanoma
- •Bladder cancer
- •Breast cancer
- •No active symptomatic CNS disease
- •No radiographically evident cerebral edema
- •Hormone receptor status:
- •Not specified
- •Male or female
- •Performance status - ECOG 0-1
- •Hemoglobin at least 9.0 g/dL
- •Platelet count at least 100,000/mm^3
- •WBC at least 3,500/mm^3
- •Absolute granulocyte count at least 1,500/mm^3
- •No coagulation disorders
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT and SGPT less than 2.5 times ULN
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Creatinine no greater than 1.5 times ULN
- •No major cardiovascular system illness
- •No major respiratory system illness
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No major systemic infection
- •At least 1 month since prior radiotherapy
- •At least 1 month since any prior anticancer therapy or adjuvant therapy
- •No other experimental treatment within 30 days prior to, during, and for 30 days after study therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (decitabine)
Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of decitabine until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
干预措施: decitabine (Drug)
Treatment (decitabine)
Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of decitabine until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
干预措施: pharmacological study (Other)
Treatment (decitabine)
Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of decitabine until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria
时间窗: 6 weeks
次要结局
未报告次要终点