NCT00003837已完成不适用
Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority
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: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
详细描述
OBJECTIVES:
- Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority.
- Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients.
- Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients.
OUTLINE: Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for one year and then every 6 months until death.
PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma
- •Tumor cells should exhibit phenotypic characteristics of these diseases
- •No CNS involvement requiring intrathecal or craniospinal radiotherapy
- •Must not be eligible for Intergroup, Cooperative Group, or local research studies of higher priority
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •ECOG 0-3 OR
- •Karnofsky 40-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 2.0 mg/dL
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 50 mL/min
- •No neuropathy grade 2 or higher
- •No history of significant neurological toxicity (grade 2 or greater) associated with prior chemotherapy or radiotherapy
- •No active seizure disorder
- •No active infection
- •No other active concurrent malignancy except curatively treated basal cell carcinoma or carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior bone marrow transplantation allowed
- •No concurrent allogeneic bone marrow transplantation
- •Chemotherapy:
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
- •No prior 506U78
- •Endocrine therapy:
- •No concurrent systemic steroid therapy
- •Radiotherapy:
- •See Disease Characteristics
- •Prior radiotherapy allowed
- •Not specified
- •No other concurrent investigational therapy
- •No concurrent treatment for seizures
排除标准
- 未提供
结局指标
主要结局
Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority
次要结局
- Toxicity
- Antitumor efficacy as defined by the rate of complete hematologic responses
研究者
研究点 (7)
Loading locations...
相似试验
已完成
2 期
S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic LeukemiaLeukemiaNCT00006020SWOG Cancer Research Network35
终止
1 期
506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver ImpairmentChronic Myeloproliferative DisordersMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesLymphomaLeukemiaNCT00004239Alliance for Clinical Trials in Oncology10
终止
2 期
506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeNCT00005982National Cancer Institute (NCI)35
已完成
2 期
506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating AgentsLeukemiaNCT00003635GlaxoSmithKline
已完成
不适用
Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic LeukemiaT-cell Childhood Acute Lymphoblastic LeukemiaUntreated Childhood Acute Lymphoblastic LeukemiaNCT00016302National Cancer Institute (NCI)100