NCT01139151已完成1 期
Phase I Study of 4'-Thio-araC in Patients With Advanced Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of 4'-thio-araC
研究概览
简要总结
The goal of this clinical research study is to find the highest tolerable dose of 4'-thio-araC (thiarabine) that can be given to patients with advanced blood cancer. The safety of this drug will also be studied and 2 different dose schedules will be tested.
详细描述
The Study Drug:
Thiarabine is designed to damage and destroy the DNA of cancer cells. This may cause the cells to die.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 study groups based on when you joined the study. The first set of 3 participants will be enrolled in Group 1, and the 2nd set of 3 participants will be enrolled in Group 2. The 3rd set of 3 participants will be enrolled in Group 1, then the 4th set of 3 participants in Group 2, and so on until all participants are enrolled.
- Group 1 will receive thiarabine for 3 days in a row in each cycle.
- Group 2 will receive thiarabine for 5 days a row in each cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) [i.e. refractory anemia with excess blasts (RAEB-1 or RAEB-2) by WHO classification] and chronic myelomonocytic leukemia (CMML) are also candidates for this protocol. Relapsed/refractory leukemias include acute non-lymphocytic leukemia (AML) by WHO classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis.
- •Patients with refractory/relapsed leukemia 16 years or older are eligible. Patients 60 years or older with newly diagnosed AML are eligible if they are not candidates for, or if they refuse, intensive chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Women of child-bearing potential (ie, a woman who has not been postmenopausal for at least 12 consecutive months or who had not undergone previous surgical sterilization) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), oral contraceptive or double barrier device), and must have a negative urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods for the duration of time on study.
- •Continued from #4: Pregnant and nursing patients are excluded because the effects of 4'-thio-araC on a fetus or nursing child are unknown.
- •Must be able and willing to give written informed consent
- •In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. If the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol. Persistent clinically significant toxicities from prior chemotherapy must not be greater than grade
- •Patients must have the following clinical laboratory values unless considered due to leukemic organ involvement:
- •Serum creatinine </= 1.3 mg/dl or creatinine clearance > 40 ml/min.
- •Total bilirubin </= 1.5* the upper limit of normal unless considered due to Gilbert's syndrome.
- •Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) </= 3* the upper limit of normal unless considered due to organ leukemic involvement.
- •Patients with active central nervous system (CNS) involvement of leukemia disease are included and will be treated concurrently with intrathecal therapy.
排除标准
- •Uncontrolled intercurrent illness including, but not limited to uncontrolled infection (e.g. requiring IV antibiotics, etc), symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, corrected QT interval (QTc) > 480, arrhythmias not controlled by medication, or uncontrolled congestive heart failure defined as Class II to IV per New York Heart Association Classification.
- •Patients receiving any other standard or investigational treatment for their hematologic malignancy.
- •Patients with known HIV positive disease; patients with active hepatitis.
研究组 & 干预措施
Group 1 - 3 Day Thiarabine
Experimental
Thiarabine 3 days in a row in each cycle.
干预措施: 3 Day Thiarabine (Drug)
Group 2 - 5 Day Thiarabine
Experimental
Thiarabine 5 days a row in each cycle.
干预措施: 5 Day Thiarabine (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of 4'-thio-araC
时间窗: 3 weeks
The MTD is the highest dose level in which \<2 patients of six develop first cycle dose-limiting toxicity (DLT).
次要结局
未报告次要终点
研究者
研究点 (1)
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