A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 71
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
- Determine the complete remission rate of patients with relapsed or refractory acute lymphoblastic leukemia treated with arsenic trioxide.
- Determine the toxic effects of induction arsenic trioxide in this patient population.
OUTLINE: Patients are stratified according to administration schedule of arsenic trioxide (5 days a week vs 7 days a week).
Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less than 5% or for a maximum of 60 days. Beginning 3-6 weeks after induction, patients achieving a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a week for 25 days. Subsequent consolidation courses are given with 4 week treatment-free intervals between courses. Treatment continues for a maximum of 5 consolidation courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •Morphologically proven acute lymphoblastic leukemia (ALL)
- •Subtypes L1, L2, or L3
- •Bone marrow morphology with greater than 25% lymphoblasts
- •ALL morphology and cytochemistry with myeloid markers eligible
- •Refractory to induction therapy or relapsed following chemotherapy or autologous blood or bone marrow transplantation
- •Any number of prior relapses allowed
- •No relapse following allogeneic transplantation
- •Prior CNS leukemia allowed if treated and currently disease-free
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 2.0 mg/dL
- •SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2 times ULN
- •Creatinine no greater than 2 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No significant active infection
- •No other medical conditions that would likely decrease life expectancy
- •No other prior malignancy within the past 5 years except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •At least 2 weeks since prior systemic corticosteroids
- •Radiotherapy:
- •Not specified
- •Not specified
- •No concurrent antibiotics for active or resolving infection
排除标准
- 未提供