NCT00020111已完成1 期
Phase I Trial and Pharmacokinetic Study of Arsenic Trioxide in Pediatric Patients With Refractory Leukemia or Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 52
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide in treating young patients with leukemia or lymphoma.
详细描述
OBJECTIVES:
- Determine the toxic effects of arsenic trioxide in pediatric patients with refractory leukemia or lymphoma.
- Determine the maximum tolerated dose of this drug in this patient population.
- Determine the plasma pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to disease (acute promyelocytic leukemia [APL] vs non-APL).
- Stratum I (APL patients): Patients receive standard-dose arsenic trioxide IV over 2 hours daily 5 days a week for 4 weeks. Treatment continues every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
- Stratum II (Non-APL patients): Cohorts of 3-6 patients receive escalating doses of arsenic trioxide (according to the stratum 1 schedule above) until the maximum tolerated dose (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. Once the MTD is determined, additional patients are accrued to receive treatment with arsenic trioxide at the recommended phase II dose.
Leukemia patients in both strata without progressive disease who have not achieved complete remission after the first 20 doses may continue to receive arsenic trioxide for 2 additional weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens
- •Measurable or evaluable disease
- •No meningeal leukemia or lymphoma
- •No HIV-related lymphoma
- •No lymphoproliferative diseases
- •PATIENT CHARACTERISTICS:
- •Acute promyelocytic leukemia (APL) patients (stratum I) must be age 2 to 12
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin normal
- •SGPT less than 2 times upper limit of normal
- •No significant hepatic dysfunction that would preclude study therapy
- •Creatinine normal (age adjusted) OR
- •Creatinine clearance at least 60 mL/min
- •Potassium, magnesium, and calcium at least lower limit of normal (oral or IV supplementation allowed)
- •No significant renal dysfunction that would preclude study therapy
- •Cardiovascular:
- •Rate corrected QTc interval no greater than 0.48 on EKG
- •No significant cardiac dysfunction that would preclude study therapy
- •No cardiac disease, including dysrhythmias
- •No significant pulmonary dysfunction that would preclude study therapy
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No persistent grade 3 or greater sensory or motor neuropathy
- •No prior grand mal seizures (grade 3 or greater) within the past 2 years other than febrile seizures (except for patients with APL at discretion of investigator)
- •No clinically significant unrelated systemic illness that would preclude study therapy (e.g., serious infection)
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 1 week since prior colony-stimulating factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], and epoetin alfa)
- •No concurrent immunotherapy
- •Chemotherapy:
- •No prior arsenic trioxide
- •At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered
- •No concurrent intrathecal chemotherapy except for acute promyelocytic leukemia (APL) patients experiencing progressive meningeal leukemia and demonstrating benefit from arsenic trioxide for systemic disease
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy:
- •No concurrent steroids (except corticosteroids for retinoic acid syndrome)
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •Not specified
- •At least 6 months since prior anticonvulsants
- •At least 1 week since prior retinoid therapy
- •No concurrent retinoids
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (52)
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