A Phase I Trial of the Combination of Oxaliplatin (NSC 266046, IND 57004), Ifosfamide, and Etoposide in Recurrent or Refractory Pediatric Solid Tumors and Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
研究概览
简要总结
This phase I trial is studying the side effects and best dose of oxaliplatin and etoposide in treating young patients with recurrent or refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may also help etoposide work better by making cancer cells more sensitive to the drug. Giving oxaliplatin together with etoposide may kill more cancer cells.
详细描述
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of oxaliplatin and etoposide in pediatric patients with recurrent or refractory solid tumors or lymphoma.
II. Determine the dose-limiting toxic effects of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetic profile of this regimen in these patients. II. Correlate the extent of oxaliplatin and etoposide exposure with toxic effects and therapeutic effects of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Life expectancy > 8 weeks
- •Albumin > 2 g/dL
- •Histologically confirmed diagnosis of 1 of the following: solid tumor; histologic verification not required for brainstem tumors or optic pathway tumors; lymphoma; recurrent or refractory to conventional therapy OR no known effective therapy exists; bone marrow involvement allowed
- •Performance Status: Karnofsky >= 50 % (patients > 10 years of age) OR Lansky >= 50% (patients for =< 10 years of age)
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3 (transfusion independent)
- •Hemoglobin > 8 g/dL (transfusion allowed)
- •ALT < 5.0 times ULN
- •Creatinine normal OR glomerular filtration rate >= 80 mL/min/1.73 m^2
- •Calcium normal (electrolyte supplements allowed)
- •Echocardiogram and EKG normal
- •Shortening fraction >= 27% OR ejection fraction > 50%
- •No evidence of dyspnea at rest
- •No exercise intolerance
- •Pulse oximetry > 94% on room air
- •Neurologic deficits due to CNS tumor must be relatively stable for >= 2 weeks before study entry
- •Seizure disorder allowed provided well-controlled by non-enzyme-inducing anticonvulsants
- •No peripheral neurotoxicity > grade 1
- •Sodium, potassium, and magnesium normal (electrolyte supplements allowed)
- •At least 1 week since prior biologic agents
- •More than 1 week since prior growth factors
- •More than 6 months since prior allogeneic peripheral blood stem cell transplantation AND no active graft-versus-host disease
- •More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
- •More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites
- •More than 6 weeks since prior substantial bone marrow radiotherapy
- •More than 3 months since prior craniospinal (> 24 Gy), whole pelvis, or total-body radiotherapy
- •Recovered from all prior therapy
- •No concurrent enzyme-inducing anticonvulsants, including, but not limited to, the following: Barbiturates; Phenytoin; Carbamazepine
排除标准
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No uncontrolled infection
- •No history of life-threatening hypersensitivity to platinum-containing agents
- •No prior oxaliplatin
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
- •Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
研究组 & 干预措施
Arm I
Patients receive oxaliplatin IV over 2 hours on day 1 and etoposide IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: oxaliplatin (Drug)
Arm I
Patients receive oxaliplatin IV over 2 hours on day 1 and etoposide IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: etoposide (Drug)
结局指标
主要结局
MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
时间窗: 21 days
MTD of the addition of ifosfamide to the combination of oxaliplatin and etoposide assessed by CTCAE version 3.0
时间窗: 21 days
次要结局
未报告次要终点