Chemotherapy in Treating Patients With Recurrent Malignant Glioma
Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of topotecan plus carmustine in patients with recurrent primary malignant glioma.
研究概览
详细说明
OBJECTIVES:
- Determine the maximum tolerated dose of topotecan administered in combination with a fixed dose of carmustine.
- Determine the toxic effects of topotecan and carmustine in patients with recurrent primary malignant glioma.
OUTLINE: Topotecan is administered by an ambulatory infusion pump for 72 hours each week. Topotecan dose escalation is carried out in cohorts of three patients. Dose escalation is continued until toxic effects or disease progression is observed in these patients. Carmustine is administered over 1 hour every 6 weeks, on the same day as the first topotecan dose for that week.
Three patients will be treated at an initial dose level of topotecan, and if one of these patients experience dose limiting toxicity (DLT), an additional
3 patients must be treated at this dose level without further DLT in order for dose escalation to proceed. The MTD is the highest dose at which DLT occurs in no more than 1 of 6 patients.
Patients are evaluated after every 6 week cycle.
PROJECTED ACCRUAL: An estimated 18-36 patients will be entered.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
-
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North Carolina
-
Durham、North Carolina、美国、27710
- Duke Comprehensive Cancer Center
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Tennessee
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Memphis、Tennessee、美国、38105-2794
- Saint Jude Children's Research Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically proven recurrent primary malignant glioma
- Measurable recurrent or residual primary central nervous system neoplasm confirmed by MRI
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance Status:
- Karnofsky at least 60%
Hematopoietic:
- Hematocrit greater than 29%
- ANC greater than 1,500/mm^3
- Platelet count greater than 125,000/mm^3
Hepatic:
- SGOT less than 1.5 times upper limit of normal (ULN)
- Bilirubin less than 1.5 times ULN
Renal:
- Creatinine less than 1.5 mg/dL
- BUN less than 25 mg/dL
Other:
- Not pregnant
- Effective contraceptive method must be used for the duration of the study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy within 6 weeks of study
- No prior topotecan or carmustine treatment failure
- No more than 1 prior chemotherapy regimen
Endocrine therapy:
- Patients taking corticosteroids must be on stable dose for at least 2 weeks prior to study and the dose should not escalate over entry level
Radiotherapy:
- No prior radiotherapy within 6 weeks of study
Surgery:
- No prior surgical resection within 3 weeks of study
Other:
- No concurrent medication that may interfere with study results
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 0224
- DUMC-000224-01-1R4
- DUMC-000224-00-2R3
- DUMC-0348-99-2R2
- DUMC-223-97-2
- DUMC-229-98-2R1
- SB-DUMC-229-98-2R1
- NCI-G97-1242
- CDR0000065521 (其他标识符:NCI)
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