NCT00003464已完成2 期
Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 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.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme.
详细描述
OBJECTIVES:
- Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme.
- Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients.
- Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide.
OUTLINE: Patients receive temozolomide orally once daily on days 1-5. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment.
Patients are followed every 8-12 weeks for 2 years.
PROJECTED ACCRUAL: This study will accrue 50 patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy
- •At least 1 bidimensionally measurable lesion
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Greater than 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1500/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)
- •SGOT and SGPT less than 2.5 times ULN
- •Alkaline phosphatase less than 2 times ULN
- •BUN less than 1.5 times ULN
- •Creatinine less than 1.5 times ULN
- •Must be neurologically stable
- •No systemic disease
- •No acute infection requiring intravenous antibiotics
- •No frequent vomiting
- •No other medical condition that would interfere with oral medication intake such as partial bowel obstruction
- •No prior or concurrent malignancies except:
- •Surgically cured carcinoma in situ of the cervix
- •Basal or squamous cell carcinoma of the skin
- •HIV negative
- •No AIDS-related illness
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior biologic therapy
- •No concurrent biologic therapy (growth factors or erythropoietin)
- •Chemotherapy:
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Concurrent steroid allowed (must be on stable dose for at least 1 week prior to study)
- •Radiotherapy:
- •No prior radiation therapy
- •No prior interstitial brachytherapy
- •No prior radiosurgery to the brain
- •Not requiring immediate radiation therapy
- •No concurrent radiotherapy
- •Recovered from any effects of prior surgery
- •At least 2 weeks since prior surgical resection
- •No other concurrent investigational drugs
排除标准
- 未提供
研究者
研究点 (2)
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