NCT00010049已完成1 期
Phase I/II Trial of STI571 (NSC 716051) in Patients With Recurrent Malignant Gliomas
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins11 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2001年2月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 11
研究概览
简要总结
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for recurrent glioma and meningioma.
PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, recurrent, or unresectable malignant glioma or meningioma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of imatinib mesylate in patients with recurrent malignant glioma or meningioma.
- Determine the safety profile of this drug in these patients.
- Determine the pharmacokinetics of this drug, with or without concurrent enzyme-inducing anti-epileptic drugs (EIAEDs), in these patients. (Stratum of patients currently taking EIAEDs closed to accrual as of 05/15/2003 for phase I and phase II)
- Determine angiogenic activity in vivo using functional neuro-imaging studies and in vitro with assays of serum angiogenic peptides.
- Determine the efficacy of this drug, in terms of 6-month progression-free survival and objective tumor response, in these patients.
OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to concurrent enzyme-inducing anti-epileptic drug use (yes [stratum closed to accrual as of 05/15/2003 for phase I and phase II] vs no).
- Phase I (patients with glioma or meningioma) Patients in cohorts 1 and 2 receive oral imatinib mesylate (STI571) once daily on days 1-28. Patients in cohorts 3-5 receive oral STI571 twice daily on days 1 and 3-28 of the first course and on days 1-28 of subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed recurrent or unresectable malignant glioma
- •Glioblastoma multiforme (phase I only)
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Anaplastic mixed oligoastrocytoma
- •Malignant astrocytoma not otherwise specified
- •Gliosarcoma
- •Low-grade histology with subsequent diagnosis of malignant glioma allowed (phase I only) OR
- •Histologically confirmed recurrent or unresectable benign or malignant meningioma (phase I only)
- •No prior intracranial hemorrhage
- •Failed prior radiotherapy
- •Progressive or recurrent disease by MRI or CT scan and/or resection
- •PET or thallium scan, MR spectroscopy, or surgical documentation required in patients who have received prior interstitial brachytherapy or stereotactic radiosurgery
- •Stable dose of steroids for 5-7 days prior to MRI or CT scan
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 8 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL (transfusion allowed)
- •Bilirubin less than 2 times upper limit of normal (ULN)
- •SGOT less than 2 times ULN
- •No significant hepatic disease
- •Creatinine less than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •No significant renal disease
- •Cardiovascular:
- •No significant cardiac disease
- •No deep venous or arterial thrombosis within the past 6 weeks
- •No pulmonary embolism within the past 6 weeks
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for up to 6 months after study participation
- •No other serious concurrent medical illness
- •No serious active infection
- •No concurrent disease that would obscure toxicity or alter drug metabolism
- •No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 1 week since prior interferon or thalidomide and recovered
- •No concurrent immunotherapy
- •No concurrent prophylactic filgrastim (G-CSF)
- •Chemotherapy:
- •Recovered from prior chemotherapy
- •At least 4 weeks since prior cytotoxic therapy
- 另有 28 项未显示
排除标准
- 未提供
研究者
研究点 (11)
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