Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Response rate (RR) defined as CR + PR rates
研究概览
简要总结
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma
详细描述
PRIMARY OBJECTIVES:
I. Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78.
II. Determine the toxicity of this drug in these patients. III. Study the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses 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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma
- •Large cell transformation of cutaneous T-cell lymphoma allowed
- •No active CNS disease
- •Performance status - Zubrod 0-2
- •Absolute neutrophil count at least 1,000/mm^3*
- •Platelet count at least 100,000/mm^3*
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGPT no greater than 2.5 times ULN
- •Creatinine clearance greater than 50 mL/min
- •No history of symptomatic cardiac dysfunction
- •No history of pericardial effusion
- •HIV negative
- •No grade 2 or greater sensory or motor neuropathy
- •No history of seizures
- •No other malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin of carcinoma in situ of the cervix
- •No medical, psychiatric, or social condition that would preclude study
- •No other concurrent serious illness or active infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior stem cell or bone marrow transplantation (BMT)
- •No more than 1 prior immunotherapy regimen
- •No more than 3 prior systemic regimens with denileukin diftitox
- •At least 3 weeks since prior biologic therapy
- •No concurrent BMT
- •No prior 506U78
- •No more than 3 prior systemic chemotherapy regimens comprising any of the following:
- •Oral methotrexate
- •Topical mechlorethamine
- •At least 3 weeks since prior chemotherapy
- •No other concurrent chemotherapy
- •At least 3 weeks since prior anticancer endocrine therapy
- •No concurrent topical or systemic steroids
- •At least 3 weeks since prior radiotherapy
- •No more than 3 prior systemic regimens comprising any of the following:
- •Total skin electron beam therapy
- •Spot radiotherapy
- •No more than 3 prior systemic regimens comprising any of the following:
- •Oral retinoids
- •Ultraviolet therapy (PUVA)
- •At least 3 weeks since prior anticancer therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (nelarabine)
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: nelarabine (Drug)
Treatment (nelarabine)
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
结局指标
主要结局
Response rate (RR) defined as CR + PR rates
时间窗: Up to 4 years
次要结局
未报告次要终点