A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 发起方
- 试验地点
- 14
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. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effect of combination chemotherapy on the body when treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and recommended dose of pixantrone when administered with cytarabine, methylprednisolone, and cisplatin in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma.
- Determine the dose-limiting toxic effects of this regimen in these patients.
- Determine the relationship between toxicity and systemic exposure to this regimen in these patients.
- Determine the safety of this regimen in these patients.
- Assess the pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the efficacy of this regimen in these patients.
OUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of pixantrone.
Patients receive pixantrone IV over 1 hour on day 1, methylprednisolone IV over 15 minutes on days 1-5, cisplatin IV over 30 minutes on days 1-4, and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pixantrone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the recommended dose, which is defined as the dose preceding the MTD.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) including the following:
- •Diffuse large B-cell lymphoma
- •Transformed NHL
- •Follicular large cell lymphoma
- •Peripheral T-cell lymphoma
- •Unclassified aggressive histology (immunoblastic lymphoma)
- •Must have received 1 to 3 prior chemotherapy treatment regimens (may include doxorubicin up to a cumulative dose of no greater than 450 mg/m^2)
- •No Burkitt's lymphoma, lymphoblastic lymphoma, or mantle cell lymphoma
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Neutrophil count at least 1,500/mm^3*
- •Platelet count at least 100,000/mm^3* NOTE: *Lower values may be accepted if evidence of bone marrow involvement
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)**
- •Alkaline phosphatase no greater than 2 times ULN**
- •AST or ALT no greater than 2 times ULN**
- •No history or clinical symptoms of hepatitis B or C virus NOTE: **Higher values may be accepted if evidence of liver involvement
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular
- •LVEF at least 50% by MUGA
- •No clinically significant cardiovascular abnormalities
- •No New York Heart Association class II-IV heart disease
- •No myocardial infarction within the past 6 months
- •No severe arrhythmia
- •No uncontrolled hypertension
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 6 months after study
- •No history or clinical symptoms of HIV
- •No clinically significant neurological abnormalities
- •No serious uncontrolled infection (NCI CTC grade 3-4)
- •No condition that would place the patient at undue risk or interfere with the study results
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 3 months since prior radioimmunotherapy
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy
- •At least 1 year since prior platinum or cytarabine (unless complete response to treatment)
- •At least 2 years since prior fludarabine or nitrosoureas
- •No prior cumulative cisplatin greater than 600 mg/m^2
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Biologic therapy
- •At least 4 weeks since prior radiotherapy
- •No prior radiotherapy to the whole pelvis
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排除标准
- 未提供