Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma
A Phase I Study Of ZD 1839 And Temozolomide For The Treatment Of Gliomas
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining gefitinib with temozolomide in treating patients who have malignant primary glioma.
研究概览
详细说明
OBJECTIVES:
- Determine the maximum tolerated dose of gefitinib when given in combination with temozolomide in patients with malignant primary glioma.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of gefitinib. Patients are stratified according to use of concurrent enzyme-inducing anti-epileptic drugs (yes vs no).
Patients receive oral gefitinib once daily on days 1-35 and oral temozolomide once daily on days 8-12 for the first course only. For the second and subsequent courses, patients receive oral gefitinib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 2 months for 1 year and then every 3-6 months thereafter.
PROJECTED ACCRUAL: Approximately 3-42 patients will be accrued for this study within 1-14 months.
研究类型
阶段
- 阶段1
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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San Francisco、California、美国、94143-0128
- UCSF Comprehensive Cancer Center
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Maryland
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Bethesda、Maryland、美国、20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Massachusetts
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Boston、Massachusetts、美国、02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Michigan
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Ann Arbor、Michigan、美国、48109-0752
- University of Michigan Comprehensive Cancer Center
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New York
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New York、New York、美国、10021
- Memorial Sloan-Kettering Cancer Center
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15232
- University of Pittsburgh Cancer Institute
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Texas
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Dallas、Texas、美国、75390-9154
- Simmons Cancer Center - Dallas
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Houston、Texas、美国、77030-4009
- University of Texas - MD Anderson Cancer Center
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San Antonio、Texas、美国、78284-6220
- University of Texas Health Science Center at San Antonio
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Wisconsin
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Madison、Wisconsin、美国、53792
- University of Wisconsin Comprehensive Cancer Center
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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 confirmed malignant primary glioma
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic mixed oligoastrocytoma
- Malignant astrocytoma not otherwise specified
Stable or progressive disease
- Progressive disease after interstitial brachytherapy or stereotactic radiosurgery must be confirmed by positron emission tomography or thallium scan, magnetic resonance spectroscopy, or surgical biopsy
- Prior treatment for no more than 3 prior relapses allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- More than 8 weeks
Hematopoietic:
- WBC greater than 3,000/mm^3
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 120,000/mm^3
- Hemoglobin greater than 10 g/dL (transfusion allowed)
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGOT less than 1.5 times ULN
Renal:
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection
- No other concurrent significant medical illness that would preclude study participation
- No significant gastrointestinal risk factors (e.g., active ulcerative colitis) within the past 6 months
- No other malignancy within the past 3 years except non-melanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 1 week since prior interferon
- No concurrent filgrastim (G-CSF) during the first course of study therapy
Chemotherapy:
- At least 2 weeks since prior vincristine
- At least 3 weeks since prior procarbazine
- At least 6 weeks since prior nitrosoureas
- Prior or concurrent temozolomide allowed if there is no evidence of progression while receiving therapy
Endocrine therapy:
- At least 1 week since prior tamoxifen
- Must be on a stable dose of corticosteroids for at least 5 days
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
- At least 1 week since prior surgical resection
Other:
- Recovered from all prior therapy
- No prior gefitinib
- At least 1 week since prior non-cytotoxic agents except radiosensitizers
- At least 4 weeks since prior cytotoxic therapy
- At least 4 weeks since prior investigational agents
- At least 3 years since prior therapy for other malignancy
- Concurrent therapeutic agents allowed at stable dosage
- Concurrent enzyme-inducing anti-epileptic drugs allowed if continued during study participation
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
调查人员
- 学习椅:Michael Prados, MD、UCSF Medical Center at Parnassus
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
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
其他相关的 MeSH 术语
其他研究编号
- NABTC-0102
- CDR0000069049 (注册表标识符:PDQ (Physician Data Query))
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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