A Phase I Study of Thiotepa in Combination With Carboplatin and Topotecan With Peripheral Blood Progenitor Cell Support for the Treatment of Children With Recurrent or Refractory Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of thiotepa in combination with carboplatin and topotecan with peripheral blood stem cell transplantation in patients with recurrent or refractory pediatric solid tumors.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a dose escalation study of thiotepa.
Patients may receive 2 courses of mobilization comprising cyclophosphamide and etoposide with filgrastim (G-CSF) support and peripheral blood stem cell (PBSC) collection.
Patients receive thiotepa IV over 2 hours on days 0 and 1; topotecan IV over 30 minutes on days 0-4; and carboplatin IV over 2 hours on days 2 and 3. Patients also receive G-CSF beginning on day 5, 24-36 hours following the last dose of topotecan. PBSC are reinfused on day 6 (36-48 hours following the last dose of topotecan) of each course of therapy. Patients receive 3 courses of therapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Year 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven recurrent or refractory pediatric solid tumor
- •Bone marrow metastases allowed
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 2 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,000/mm3
- •Platelet count at least 100,000/mm3 (transfusion independent)
- •Hemoglobin at least 10 g/dL (RBC transfusion allowed)
- •Bilirubin no greater than 1.5 times normal
- •SGOT no greater than 2.5 times normal
- •Adequate renal function as defined by one of the following:
- •GFR by creatinine clearance
- •Radioisotope GFR
- •Iothalamate at least 70 mL/min
- •Cardiovascular:
- •Adequate cardiac function as defined by one of the following:
- •Ejection fraction at least 55% by MUGA
- •Fractional shortening at least 28% by echocardiogram
- •Neurologic:
- •Adequate CNS function as defined by:
- •Seizure disorder, if present, controlled by anticonvulsants
- •CNS toxicity no greater than grade 2
- •No uncontrolled infections
- •Not pregnant or nursing
- •No allergy to platinum compounds
- •No history of allergy to etoposide (unless mobilization phase not required)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Recovered from prior immunotherapy
- •At least 1 week since prior cytokines
- •At least 3 months since prior bone marrow or peripheral blood stem cell transplantation
- •No concurrent immunomodulator
- •No concurrent cytokines
- •Chemotherapy:
- •At least 3 weeks (6 for nitrosourea) since prior chemotherapy and recovered
- •No prior thiotepa
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Recovered from prior radiotherapy
- •At least 6 months since prior total body irradiation conditioning
- •No concurrent radiotherapy to greater than 10% of total liver, lung, or bone marrow
- •Not specified
排除标准
- 未提供
研究者
Doug Hawkins
Investigator
Seattle Children's Hospital