NCT00006656Unknown2 期
A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
Direct Therapeutics24 个研究点 分布在 1 个国家开始时间: 2000年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 24
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.
PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in patients with unresectable recurrent glioblastoma multiforme. (Phase I of this study closed to accrual as of 01/15/2002.)
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Assess the activity of this regimen in these patients.
- Estimate peripheral blood carmustine levels in these patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during stereotactic biopsy or open craniotomy.
Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. (Phase I of this study closed to accrual as of 01/15/2002.)
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 75 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 glioblastoma multiforme
- •Clear evidence of disease progression by MRI
- •Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated)
- •Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm
- •No brainstem (pons or medulla) or midbrain (mesencephalon) involvement
- •No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve
- •No tumor extension into the ventricular system
- •Tumor volume no greater than 33.4 cm3
- •At least one prior radiotherapy
- •PATIENT CHARACTERISTICS:
- •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
- •No evidence of bleeding diathesis
- •Bilirubin no greater than 2.0 mg/dL
- •SGOT/SGPT no greater than 2.5 times normal
- •Creatinine no greater than 2.0 mg/dL OR
- •Creatinine clearance at least 40 mL/min
- •BUN no greater than 30 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active uncontrolled infection
- •Afebrile unless fever due to presence of tumor
- •No other concurrent serious medical or psychiatric illness that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy and recovered
- •No prior intracranial brachytherapy
- •Recovered from any prior surgery
- •No prior anticoagulants
- •No other concurrent investigational agents
排除标准
- 未提供
研究者
研究点 (24)
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