NCT00119301已完成1 期
Phase I Study of High Dose Methotrexate With Simultaneous Trimetrexate and Leucovorin in Patients With Recurrent Osteosarcoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) after 1 course of treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as methotrexate, trimetrexate glucuronate, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of trimetrexate glucuronate when given together with methotrexate and leucovorin in treating patients with refractory or recurrent osteosarcoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of trimetrexate glucuronate when administered with high-dose methotrexate and leucovorin calcium in patients with refractory or recurrent high-grade osteosarcoma.
Secondary
- Determine the dose-limiting toxic effects of this regimen in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
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 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignant osteosarcoma
- •High-grade disease
- •Recurrent or refractory disease after prior standard chemotherapy comprising methotrexate, doxorubicin, cisplatin, and ifosfamide
- •No low-grade osteosarcoma
- •No parosteal or periosteal sarcoma
- •No osteosarcoma arising in premalignant bony lesions (e.g., Paget's disease) OR in a prior radiotherapy field
- •No symptomatic or known brain or leptomeningeal involvement
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 70-100% (for patients > 16 years of age)
- •Lansky 70-100% (for patients ≤ 16 years of age)
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 75,000/mm^3
- •Bilirubin ≤ 1.5 times normal
- •AST and ALT ≤ 5 times normal
- •Albumin ≥ 2 g/dL
- •No clinically significant liver disease
- •Creatinine ≤ 1.5 times normal OR
- •Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of normal
- •Cardiovascular
- •Shortening fraction ≥ 27% by echocardiogram OR
- •Ejection fraction ≥ 50% by gated radionuclide study
- •No congestive heart failure
- •No angina pectoris
- •No myocardial infarction within the past year
- •No uncontrolled arterial hypertension
- •No uncontrolled arrhythmias
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No history of significant neurological or psychiatric disorder
- •No active infection
- •No symptomatic peripheral neuropathy ≥ grade 2
- •No other serious illness or medical condition
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 7 days since prior biologic therapy
- •At least 6 months since prior allogeneic stem cell transplantation AND no evidence of active graft-versus-host disease
- •No concurrent sargramostim (GM-CSF)
- •Chemotherapy
- •See Disease Characteristics
- •More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas)
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- 另有 9 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose (MTD) after 1 course of treatment
Dose-limiting toxicities as assessed by hematology and biochemistry testing on days 1, 8, and 28 of each course
次要结局
- Antitumor activity as measured by radiographic response using RECIST criteria after every 2 courses of treatment
- Antitumor activity as measured by pathologic response using the Huvos grading system to evaluate post-treatment tumor necrosis at time of tumor resection after completion of study treatment
研究者
研究点 (1)
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