NCT00079092已完成2 期
A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion
研究概览
简要总结
RATIONALE: Thalidomide may stop the growth of malignant glioma by stopping blood flow to the tumor. Drugs used in chemotherapy, such as procarbazine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with procarbazine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving thalidomide together with procarbazine works in treating patients with recurrent or progressive malignant glioma.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with recurrent or progressive malignant glioma treated with thalidomide and procarbazine.
Secondary
- Determine the progression-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the toxicity of this regimen 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 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
- •Anaplastic oligodendroglioma
- •Glioblastoma multiforme
- •Anaplastic mixed oligoastrocytoma
- •Progressive or recurrent disease* after radiotherapy with or without chemotherapy NOTE: *Patients with prior low-grade glioma who progressed after therapy and are found to have high-grade glioma are eligible
- •Measurable disease by MRI or CT scan
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •More than 2 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 mg/dL
- •Transaminases ≤ 4 times upper limit of normal
- •Creatinine ≤ 1.7 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 1 highly active method and 1 additional effective method of contraception for 1 month before, during, and for 4 weeks after study treatment
- •No concurrent serious infection
- •No other concurrent medical illness that would preclude study treatment
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior thalidomide
- •No concurrent prophylactic filgrastim (G-CSF)
- •Chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •No prior procarbazine
- •No more than 2 prior chemotherapy regimens for malignant glioma
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •At least 3 months since prior radiotherapy
- •Recovered from prior therapy
- •More than 7 days since prior antidepressants (selective serotonin reuptake inhibitors and/or monamine oxidase inhibitors)
- •No concurrent antidepressants
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion
次要结局
- Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion
- Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion
- Toxicity by evaluation form at baseline, pre-odd cycles, and study completion
- Overall survival by follow-up form at study completion
研究者
研究点 (5)
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