A Phase I Study Of Taxol And Involved Field Radiation Therapy For Newly Diagnosed Intrinsic Gliomas Of Childhood
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 4
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel with radiation therapy in treating children who have newly diagnosed brain stem glioma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of paclitaxel when combined with involved-field radiotherapy in children with newly diagnosed, diffuse, intrinsic brain stem glioma.
- Determine the toxicity of this regimen in these patients.
- Assess the antitumor activity of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of paclitaxel.
Patients receive induction therapy comprising paclitaxel intravenously (IV) over 1 hour once weekly and involved-field radiotherapy (after paclitaxel infusion) once daily, 5 days a week, for 6 weeks.
Beginning 6 weeks after completion of induction therapy, patients may receive maintenance therapy comprising paclitaxel IV over 1 hour once every 3 weeks for a total of 8 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Newly diagnosed, diffuse, intrinsic brain stem glioma by clinical examination and magnetic resonance imaging (MRI)
- •Histologic verification not required
- •Intrinsic (more than 50% intra-axial) involvement of the pons, pons and medulla, pons and midbrain, or entire brain stem allowed
- •Contiguous involvement of the thalamus or upper cervical cord allowed
- •PATIENT CHARACTERISTICS:
- •3 to 21 at diagnosis
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,000/mm3
- •Platelet count greater than 100,000/mm3
- •Hemoglobin greater than 10.0 g/dL
- •Bilirubin less than 1.5 times normal
- •serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than 2.5 times normal
- •Creatinine less than 1.5 times normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use a highly effective method of contraception for female patients or barrier contraception for male patients
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy:
- •Concurrent corticosteroid therapy for increased intracranial pressure allowed
- •Radiotherapy:
- •Not specified
- •Not specified
- •No concurrent cytochrome P450-inducing anticonvulsants (e.g., phenytoin or carbamazepine) during paclitaxel therapy
- •Other concurrent anticonvulsants (e.g., valproic acid) for pre-existing seizure disorder allowed
排除标准
- 未提供