NCT00036660已完成2 期
A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 5
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 sarCNU in treating patients who have recurrent malignant glioma.
详细描述
OBJECTIVES:
- Determine the efficacy of SarCNU, in terms of objective response and duration of response, in patients with recurrent malignant gliomas.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the time to progression and survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks and then every 3 months thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 malignant glioma
- •Anaplastic astrocytoma (AA) OR
- •Glioblastoma multiforme (GBM)
- •Recurrent or progressive disease by contrast-enhanced CT scan or MRI after primary surgery and radiotherapy
- •At least 1 bidimensionally measurable lesion
- •At least 1 cm by 1 cm on contrast-enhanced CT scan or MRI
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm3
- •Platelet count at least 120,000/mm3
- •Bilirubin normal
- •AST and ALT no greater than 2.5 times upper limit of normal
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •DLCO at least 70% of predicted
- •FVC at least 70% of predicted
- •No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
- •No ongoing or active uncontrolled infection
- •No other serious illness or medical condition that would preclude study
- •No history of significant neurologic or psychiatric disorder that would preclude study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 3 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 6 weeks since prior immunotherapy
- •No concurrent immunotherapy
- •Chemotherapy:
- •At least 6 weeks since prior chemotherapy
- •No more than 1 prior adjuvant chemotherapy regimen for AA
- •No prior chemotherapy for recurrent disease
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Patients must be on a stable dose of steroids for at least 2 weeks prior to study
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy
- •No prior radiotherapy for recurrent disease
- •No concurrent radiotherapy
- •See Disease Characteristics
- •Prior surgery for recurrent disease (e.g., stereotactic biopsy or partial resection) allowed
- 另有 4 项未显示
排除标准
- 未提供
研究者
研究点 (5)
Loading locations...
相似试验
已完成
2 期
SarCNU in Treating Patients With Recurrent or Metastatic Colorectal CancerColorectal CancerNCT00028015NCIC Clinical Trials Group18
已完成
1 期
Chemotherapy in Treating Patients With Advanced Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00003703Jewish General Hospital
Unknown
2 期
Docetaxel Plus Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung CancerLung CancerNCT00003562Hope Cancer Institute, Inc.38
Unknown
2 期
Chemotherapy, Surgery, Radiation Therapy and Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Primary CNS Germ Cell TumorsBrain and Central Nervous System TumorsNCT00025324Children's Hospital Los Angeles
已完成
1 期
UCN-01 in Treating Patients With Advanced CancerUnspecified Adult Solid Tumor, Protocol SpecificLymphomaLeukemiaNCT00003289Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins