NCT00006093已完成1 期
A Phase I/II Trial of EMD 121974 for Treatment of Patients With Recurrent Anaplastic Gliomas
New Approaches to Brain Tumor Therapy Consortium20 个研究点 分布在 1 个国家开始时间: 2000年9月1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
- 发起方
- 试验地点
- 20
研究概览
简要总结
RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of EMD 121974 in treating patients who have progressive or recurrent malignant glioma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of EMD 121974 in patients with progressive or recurrent malignant glioma.
- Determine the 6-month progression-free survival, clinical response rate, duration of progression-free survival, and overall survival in patients treated with this drug.
- Determine the effects of this drug on tumor perfusion, measured with magnetic resonance perfusion scan, and markers for angiogenesis in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6-12 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 2 of 6 or 4 of 12 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy and/or chemotherapy
- •Eligible subtypes:
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Glioblastoma multiforme
- •Prior low-grade glioma that has progressed to a high-grade glioma (by biopsy) after radiotherapy and/or chemotherapy allowed
- •Measurable disease by volumetric and magnetic resonance perfusion scan
- •Prior biopsy or resection of recurrent brain tumor allowed
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •Transaminases no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No advanced coronary artery disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No serious concurrent infection or medical illness that would preclude study
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
- •No history of wound healing disorders
- •No peptic ulcer disease within the past year
- •Mini mental score of at least 15
- •Willing and able to undergo MRI
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent filgrastim (G-CSF)
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- •No more than 2 prior chemotherapy regimens
- •Endocrine therapy:
- •Prior corticosteroids allowed if on stable dose for at least 5 days prior to study
- •Concurrent corticosteroids (e.g., dexamethasone) allowed as clinically needed
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 months since prior radiotherapy and recovered
- •See Disease Characteristics
- •At least 1 week since prior surgery and recovered
- •No concurrent elective surgery or dental extractions
- •No other concurrent investigational agents
排除标准
- 未提供
研究者
研究点 (20)
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