Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
Phase I-II Trial of CPT-11 and Temozolomide (Temodar) in Patients With Recurrent Malignant Glioma
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/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.
研究概览
详细说明
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan when administered with temozolomide in patients with recurrent malignant glioma.
- Determine the safety profile of this regimen in this patient population.
- Determine the efficacy of this treatment regimen as measured by 6-month progression-free survival and objective tumor response in these patients.
- Characterize the pharmacokinetics of this treatment regimen in these patients.
- Determine the antitumor activity of this treatment regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of irinotecan. Patients are stratified according to concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., phenytoin, phenobarbital, carbamazepine, or primidone) (yes vs no).
In phase I of the study, patients receive oral temozolomide on days 1-5 and irinotecan IV over 90 minutes on days 1 and 14. Treatment continues every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients concurrently on EIAEDs undergo dose escalation of irinotecan. Cohorts of 3 to 6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.
In phase II of the study, patients receive the same treatment as in phase I at the MTD.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months until progression, and then every 4 months for survival.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for phase I within 10 months and 48 patients will be accrued for phase II within 6-8 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
- Jonsson Comprehensive Cancer Center, UCLA
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San Francisco、California、美国、94143
- 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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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
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
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Texas
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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 supratentorial malignant primary glioma of one of the following subtypes:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Mixed malignant glioma
- Original histology of low-grade glioma allowed if subsequent histological confirmation of malignant glioma
Measurable recurrent or residual primary disease by MRI
- Lesions with clearly defined margins
- Evidence of tumor recurrence or progression by MRI or CT scan
- Confirmation of true progressive disease by PET or thallium scan, magnetic resonance spectroscopy, or surgical documentation after prior interstitial brachytherapy or stereotactic radiosurgery
- No more than 3 relapses after prior chemotherapy/cytotoxic therapy (including polifeprosan 20 with carmustine implant) for phase I and no more than 2 relapses for phase II
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No uncontrolled hypertension, unstable angina, or symptomatic congestive heart failure
- No myocardial infarction within the past 6 months
- No serious uncontrolled cardiac arrhythmia
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No mental incapacitation
- HIV negative
- No AIDS-related disease
- No significant ongoing alcoholism or substance abuse
- No severe nonmalignant systemic disease
- No active infection
- No other severe disease that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 1 week since prior interferon or thalidomide and recovered
- No concurrent anticancer immunotherapy
- No concurrent sargramostim (GM-CSF)
- No concurrent prophylactic filgrastim (G-CSF) during first course of study therapy
Chemotherapy:
- See Disease Characteristics
- Recovered from prior chemotherapy
- At least 2 weeks since prior vincristine
- At least 3 weeks since prior procarbazine
- At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosourea)
- Prior radiosensitizers allowed
- No prior temozolomide or irinotecan
- No other concurrent anticancer chemotherapy
Endocrine therapy:
- At least 1 week since prior tamoxifen and recovered
- No concurrent anticancer hormonal therapy
Phase II:
- Non-increasing dose of corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent anticancer radiotherapy
Surgery:
- See Disease Characteristics
- At least 1-3 weeks since prior surgical resection and recovered
Other:
- At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) and recovered
- Concurrent enzyme-inducing anti-epileptic drugs with or without steroids allowed
- No concurrent valproic acid as a single agent
- No concurrent medication that would preclude study (e.g., nonsteroidal immunosuppressive agents)
- No other concurrent investigational drugs
- No concurrent participation in other clinical study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
合作者和调查者
调查人员
- 学习椅:Wai-Kwan A. Yung, MD、M.D. Anderson Cancer Center
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-9907
- CDR0000068037 (注册表标识符:PDQ (Physician Data Query))
- UCLA-0006095
- NCI-2012-02353 (注册表标识符:CTRP (Clinical Trials Reporting System))
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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