Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan (CPT-11)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of carmustine wafers plus irinotecan in treating patients with recurrent supratentorial high grade gliomas.
详细描述
OBJECTIVES:
- Define the maximum tolerated dose of irinotecan given in combination with Gliadel wafers (carmustine) in patients with recurrent glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma.
- Define the toxicity of irinotecan given in combination with Gliadel wafers in these patients.
OUTLINE: This is a dose escalation study.
All patients undergo surgical resection. At the time of surgery, up to eight Gliadel wafers (containing carmustine) are implanted in the resected tumor cavity.
Cohorts of 3 patients each receive escalating doses of irinotecan IV over 90 minutes once weekly within 3 weeks after Gliadel wafer implantation. One course of treatment consists of 4 weeks of irinotecan and 2 weeks of rest. If 1 patient experiences dose limiting toxicity (DLT) at a dose level, an additional 3 patients are entered at that same dose level. If 2 patients experience DLT, the maximum tolerated dose (MTD) has been surpassed and a total of 6 patients are treated at the previous dose level. The MTD is defined as the highest dose in which no more than 1 of 6 patients experiences DLT.
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 confirmed recurrent supratentorial glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma
- •Must be able to undergo surgical resection
- •At least 1 bidimensionally measurable lesion documented on Gd-MRI within 72 hours after surgical implantation of Gliadel wafers
- •Not requiring immediate radiotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Greater than 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 125,000/mm^3
- •Hematocrit at least 29%
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •SGOT or 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
- •Neurological:
- •Must be neurologically stable
- •HIV negative
- •No AIDS-related illness
- •No nonmalignant systemic disease that would make patient a poor medical risk
- •No acute infection requiring intravenous antibiotics
- •Not pregnant or nursing
- •Negative pregnancy test 24 hours prior to study
- •Effective contraception required of all fertile patients
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior irinotecan
- •At least 6 weeks since chemotherapy unless there is unequivocal evidence of tumor progression after chemotherapy
- •Endocrine therapy:
- •At least 1 week of nonincreasing dose of steroids prior to study
- •Radiotherapy:
- •At least 6 weeks since radiotherapy unless there is unequivocal evidence of tumor progression after radiotherapy
- •No concurrent radiotherapy
- •Not specified
排除标准
- 未提供