NCT00004147已完成1 期
A Phase I/II Study of Col-3 Administered on a Continuous Daily Oral Schedule in Patients With Recurrent High-Grade Astrocytoma
New Approaches to Brain Tumor Therapy Consortium18 个研究点 分布在 1 个国家开始时间: 2000年7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
- 18
研究概览
简要总结
RATIONALE: COL-3 may stop the growth of brain tumors by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of COL-3 in treating patients who have progressive or recurrent brain tumors following radiation therapy or chemotherapy.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose, dose limiting toxicity, and safety profile of oral COL-3 alone or when combined with anticonvulsants known to be metabolized by CYP450 in patients with progressive or recurrent high grade anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme.
- Define the pharmacokinetics and pharmacodynamics of COL-3 on this schedule and determine the effects of hepatic enzyme inducing drugs, such as anticonvulsants, on the pharmacokinetics.
- Determine the response rate, disease free survival, and survival in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study of COL-3. Patients are stratified by anticonvulsant (anticonvulsants that cause induction of CYP450 vs anticonvulsants that cause modest or no induction of CYP450 or no anticonvulsant).
- Phase I: Patients receive oral COL-3 daily. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of COL-3 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
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 proven high grade glioma that is progressive or recurrent following radiotherapy or chemotherapy
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Glioblastoma multiforme
- •Prior low grade glioma that has progressed to high grade glioma following radiotherapy and/or chemotherapy allowed
- •Measurable disease by MRI or CT scan
- •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
- •SGOT or SGPT no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular:
- •No myocardial infarction, stroke, or congestive heart failure within the past 3 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 1 month after study
- •No serious active infection or medical illness that would preclude compliance
- •HIV negative
- •No history of gastrointestinal disorders that would interfere with absorption of study drug
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or breast, or basal cell or squamous cell skin cancer
- •No hypersensitivity to tetracyclines or its derivatives
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent filgrastim (G-CSF)
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas) and recovered
- •No more than 2 prior chemotherapy regimens
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior large field radiotherapy (greater than 20% of total bone marrow)
- •At least 3 months since other prior radiotherapy and recovered
- •No prior major upper gastrointestinal surgery
- •At least 14 days since other prior major surgery
- •No other concurrent investigational agents
- •No prolonged sun exposure
排除标准
- 未提供
研究者
研究点 (18)
Loading locations...
相似试验
已完成
1 期
CC-5013 in Treating Patients With Recurrent GliomaBrain and Central Nervous System TumorsNCT00036894National Cancer Institute (NCI)
终止
2 期
A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's SarcomaAIDS-related Kaposi SarcomaHIV InfectionNCT00020683National Cancer Institute (NCI)70
已完成
2 期
Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant GliomaBrain and Central Nervous System TumorsNCT00079092Wake Forest University Health Sciences18
已完成
1 期
CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous TherapySmall Intestine CancerUnspecified Adult Solid Tumor, Protocol SpecificLymphomaNCT00031941National Institutes of Health Clinical Center (CC)
已完成
2 期
Penicillamine, Low Copper Diet, and Radiation Therapy in Treating Patients With GlioblastomaBrain and Central Nervous System TumorsNCT00003751Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins40