NCT00004868已完成1 期
A Phase I/II Trial of SU5416 in Patients With Recurrent High Grade Astrocytomas or Mixed Gliomas
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 12
研究概览
简要总结
RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.
详细描述
OBJECTIVES: Phase I:
- Determine the maximum tolerated dose of SU5416 in patients with recurrent malignant glioma who are, as well as those who are not, taking enzyme-inducing antiepileptic drugs.
- Determine the toxic effects (safety profile) of this drug in this patient population.
- Characterize the pharmacokinetics of this drug in these patients.
- Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo, including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides.
Phase II:
- Determine the efficacy of SU5416, in terms of 6-month progression-free survival, in patients with recurrent high-grade glioma.
- Determine, further, the safety profile of the phase II dose of this drug in this patient population.
- Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (no vs yes).
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven supratentorial malignant primary glioma, including:
- •Glioblastoma multiforme
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Anaplastic mixed oligoastrocytoma
- •Malignant astrocytoma not otherwise specified
- •Benign or malignant meningiomas, including brain and spinal meningiomas
- •Patients with meningiomas are excluded from phase II portion of study
- •Must have shown unequivocal evidence of tumor recurrence or progression by CT scan or MRI
- •Must have failed prior radiotherapy
- •Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose within the past 14 days
- •Must be on stable (unchanged) dose of steroids for at least 5 days before scans
- •Phase II:
- •Must have completed radiotherapy at least 2 months prior to enrollment
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 8 weeks
- •Hematopoietic:
- •WBC at least 2,300/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 8 g/dL (transfusion allowed)
- •SGOT less than 2.5 times upper limit of normal
- •Bilirubin normal
- •No significant active hepatic disease
- •Creatinine less than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •No significant active renal disease
- •Cardiovascular:
- •No uncompensated coronary artery disease on ECG or physical examination
- •No history of myocardial infarction or severe/unstable angina within the past 6 months
- •No deep venous or arterial thrombosis within the past 3 months
- •No pulmonary embolism within the past 3 months
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 2 months after study
- •No other serious concurrent illness
- •No significant active psychiatric disease
- •No diabetes mellitus with severe peripheral vascular disease
- •No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No serious active infection
- •No other concurrent disease that would obscure toxic effects or dangerously alter drug metabolism
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior biologic therapy (e.g., interferon) and recovered
- •No concurrent immunotherapy
- •Chemotherapy:
- •No more than 2 prior chemotherapy regimens for recurrent disease
- 另有 16 项未显示
排除标准
- 未提供
研究者
研究点 (12)
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