Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
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. Chemotherapy combined with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by radiation therapy in treating children who have newly diagnosed malignant central nervous system tumors.
详细描述
OBJECTIVES:
- Determine the response rate to treatment with temozolomide in children with newly diagnosed malignant central nervous system tumors.
- Determine the toxicity of this treatment in these patients.
- Determine the overall survival in these patients for 18 months following the study after receiving this treatment.
OUTLINE: Patients are stratified according to type of disease (ependymoma vs brain stem glioma vs malignant glioma vs other).
Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial or complete response may receive an additional 8 courses of temozolomide following radiotherapy.
PROJECTED ACCRUAL: A maximum of 100 patients (25 per stratum) will be accrued for this study over 24-36 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed newly diagnosed malignant central nervous system tumor not requiring immediate radiotherapy
- •Patients with diffuse pontine tumors do not require histological confirmation
- •Eligible types include the following:
- •Ependymoma
- •Malignant glioma
- •Anaplastic astrocytoma
- •Glioblastoma multiforme
- •Anaplastic oligodendroglioma
- •Gliosarcoma
- •Anaplastic mixed oligoastrocytoma
- •Brainstem glioma
- •Primitive neuroectodermal tumor
- •Nongerminoma germ cell tumor
- •At least one bidimensionally measurable lesion
- •At least 1.5 cm2 within 72 hours of surgical resection or greater than 14 days after surgery
- •Diffuse pontine tumors are not required to be measurable
- •Neurologically stable
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky or Lansky 70-100%
- •Life expectancy:
- •Greater than 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 2 times ULN
- •SGOT and SGPT less than 2.5 times ULN
- •BUN and creatinine less than 1.5 times ULN
- •Must be able to swallow capsules
- •No acute infection treated with intravenous antibiotics
- •No nonmalignant systemic disease that makes patient a poor medical risk
- •No frequent vomiting or medical condition that may interfere with oral medication intake (e.g., partial bowel obstruction)
- •No other prior or concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No more than one prior biologic therapy regimen
- •No concurrent biologic therapy
- •No concurrent growth factors or epoetin alfa
- •Chemotherapy:
- •No more than one prior chemotherapy regimen
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No increasing doses of steroids within one week of study
- 另有 5 项未显示
排除标准
- 未提供