NCT00087061已完成1 期
Oral ST1481 in Adults With Malignant Glioma: A Phase I-II Clinical Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in treating patients with recurrent or progressive primary malignant glioma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of gimatecan in patients with recurrent or progressive primary malignant glioma treated with or without concurrent enzyme-inducing anticonvulsant drugs.
- Determine whether this drug has sufficient activity to warrant further development in these patients. (phase II)
Secondary
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the pharmacokinetic behaviors of this drug in these patients.
- Correlate the principal toxic effects with the pertinent pharmacokinetic parameters of this drug in these patients.
- Determine the antitumor activity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 (glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma)
- •Recurrent or progressive primary CNS neoplasm by contrast-enhanced MRI
- •Tumor progression after prior surgery, radiotherapy, or chemotherapy
- •Measurable or evaluable disease
- •Failed prior standard curative or palliative therapy (phase I only)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •SGPT and SGOT ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present)
- •Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- •Bilirubin normal
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •No myocardial infarction with the past year
- •No heart failure (including cardiac insufficiency controlled by digitalis and diuretics)
- •No irreversible arrhythmias requiring permanent medication
- •No uncontrolled hypertension
- •Gastrointestinal
- •No gastrointestinal dysfunction that would alter absorption or motility, such as any of the following:
- •Active peptic ulcer
- •Inflammatory bowel disease
- •Known intolerance to lactose
- •Malabsorption syndromes
- •Intestinal sub-occlusion
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •No active infection
- •No mentally incapacitated patients
- •No other concurrent severe disease that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •No more than 1 prior chemotherapy regimen
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Concurrent corticosteroids allowed if dose stable for the past 2 weeks
- •No concurrent hormonal therapy
- •Radiotherapy
- •See Disease Characteristics
- 另有 12 项未显示
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Malignant Glioma.Malignant GliomaNCT00032903Sigma-Tau Research, Inc.59
已完成
2 期
Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain TumorBrain and Central Nervous System TumorsNCT00004068St. Jude Children's Research Hospital53
已完成
2 期
Irinotecan in Treating Patients With Recurrent GliomaBrain and Central Nervous System TumorsNCT00003134Alliance for Clinical Trials in Oncology64
Unknown
3 期
Carboplatin Plus Vincristine in Treating Children and Adolescents With Low Grade GliomaBrain and Central Nervous System TumorsNCT00003015Societe Internationale d'Oncologie Pediatrique200
Unknown
2 期
Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic CancerPancreatic CancerNCT00006117GERCOR - Multidisciplinary Oncology Cooperative Group