S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors
2013年1月2日 更新者：Southwest Oncology Group
Phase II Study of Temozolomide in Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)
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 patients who have unresectable or metastatic gastrointestinal stromal tumors.
研究概览
详细说明
OBJECTIVES:
- Determine the complete and partial response (confirmed and unconfirmed) in patients with unresectable or metastatic gastrointestinal stromal tumors treated with temozolomide.
- Determine the qualitative or quantitative toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving a confirmed complete response (CR) receive 2 additional courses after a confirmed CR.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 13-27 months.
研究类型
介入性
注册 (实际的)
25
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Mobile、Alabama、美国、36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix、Arizona、美国、85006-2726
- CCOP - Western Regional, Arizona
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Phoenix、Arizona、美国、85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
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Tucson、Arizona、美国、85723
- Veterans Affairs Medical Center - Tucson
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Tucson、Arizona、美国、85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock、Arkansas、美国、72205
- University of Arkansas for Medical Sciences
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Little Rock、Arkansas、美国、72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte、California、美国、91010
- City of Hope Comprehensive Cancer Center
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Long Beach、California、美国、90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles、California、美国、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles、California、美国、90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles、California、美国、90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez、California、美国、94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland、California、美国、94609-3305
- CCOP - Bay Area Tumor Institute
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Orange、California、美国、92868
- Chao Family Comprehensive Cancer Center
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Sacramento、California、美国、95817
- University of California Davis Cancer Center
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San Francisco、California、美国、94143-0128
- UCSF Comprehensive Cancer Center
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Santa Rosa、California、美国、95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base、California、美国、94535
- David Grant Medical Center
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Colorado
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Denver、Colorado、美国、80220
- Veterans Affairs Medical Center - Denver
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Denver、Colorado、美国、80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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District of Columbia
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Washington、District of Columbia、美国、20060
- MBCCOP - Howard University Cancer Center
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Georgia
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Atlanta、Georgia、美国、30342-1701
- CCOP - Atlanta Regional
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Fort Gordon、Georgia、美国、30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu、Hawaii、美国、96859-5000
- Tripler Army Medical Center
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Honolulu、Hawaii、美国、96813
- MBCCOP - Hawaii
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Honolulu、Hawaii、美国、96813-2424
- Cancer Research Center of Hawaii
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Illinois
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Chicago、Illinois、美国、60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago、Illinois、美国、60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Decatur、Illinois、美国、62526
- CCOP - Central Illinois
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Hines、Illinois、美国、60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood、Illinois、美国、60153-5500
- Loyola University Medical Center
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Kansas
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Kansas City、Kansas、美国、66160-7353
- University of Kansas Medical Center
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Wichita、Kansas、美国、67214-3882
- CCOP - Wichita
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Wichita、Kansas、美国、67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington、Kentucky、美国、40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington、Kentucky、美国、40502-2236
- Veterans Affairs Medical Center - Lexington
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Louisiana
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New Orleans、Louisiana、美国、70112
- Tulane University School of Medicine
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New Orleans、Louisiana、美国、70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans、Louisiana、美国、70112
- MBCCOP - LSU Health Sciences Center
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Shreveport、Louisiana、美国、71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport、Louisiana、美国、71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston、Massachusetts、美国、02118
- Boston Medical Center
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Jamaica Plain、Massachusetts、美国、02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor、Michigan、美国、48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor、Michigan、美国、48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor、Michigan、美国、48109-0912
- University Of Michigan Comprehensive Cancer Center
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Detroit、Michigan、美国、48202
- Henry Ford Hospital
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Detroit、Michigan、美国、48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit、Michigan、美国、48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids、Michigan、美国、49503
- CCOP - Grand Rapids
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Royal Oak、Michigan、美国、48073-6769
- CCOP - Beaumont
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Southfield、Michigan、美国、48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth、Minnesota、美国、55805
- CCOP - Duluth
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Mississippi
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Biloxi、Mississippi、美国、39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson、Mississippi、美国、39216-4505
- University of Mississippi Medical Center
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Jackson、Mississippi、美国、39216
- Veterans Affairs Medical Center - Jackson
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Missouri
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Kansas City、Missouri、美国、64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City、Missouri、美国、64131
- CCOP - Kansas City
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Saint Louis、Missouri、美国、63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis、Missouri、美国、63110
- St. Louis University Health Sciences Center
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Springfield、Missouri、美国、65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings、Montana、美国、59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque、New Mexico、美国、87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque、New Mexico、美国、87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany、New York、美国、12208
- Veterans Affairs Medical Center - Albany
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New York、New York、美国、10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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Rochester、New York、美国、14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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North Carolina
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Winston-Salem、North Carolina、美国、27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati、Ohio、美国、45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati、Ohio、美国、45267-0501
- Barrett Cancer Center
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Cleveland、Ohio、美国、44195-9001
- Cleveland Clinic Taussig Cancer Center
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Columbus、Ohio、美国、43206
- CCOP - Columbus
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Dayton、Ohio、美国、45428
- Veterans Affairs Medical Center - Dayton
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Dayton、Ohio、美国、45429
- CCOP - Dayton
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Toledo、Ohio、美国、43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Oklahoma City、Oklahoma、美国、73104
- University of Oklahoma Health Sciences Center
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Oklahoma City、Oklahoma、美国、73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland、Oregon、美国、97207
- Veterans Affairs Medical Center - Portland
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Portland、Oregon、美国、97225
- CCOP - Columbia River Oncology Program
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Portland、Oregon、美国、97201-3098
- Oregon Cancer Institute
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South Carolina
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Charleston、South Carolina、美国、29425
- Hollings Cancer Center at Medical University of South Carolina
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Charleston、South Carolina、美国、29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville、South Carolina、美国、29615
- CCOP - Greenville
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Spartanburg、South Carolina、美国、29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis、Tennessee、美国、38103
- University of Tennessee Cancer Institute
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Memphis、Tennessee、美国、38104
- Danville Radiation Therapy Center
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Texas
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Amarillo、Texas、美国、79106
- Harrington Cancer Center
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Amarillo、Texas、美国、79106
- Veterans Affairs Medical Center - Amarillo
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Dallas、Texas、美国、75216
- Veterans Affairs Medical Center - Dallas
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Fort Sam Houston、Texas、美国、78234-6200
- Brooke Army Medical Center
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Galveston、Texas、美国、77555-0565
- University of Texas Medical Branch
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Houston、Texas、美国、77030
- Veterans Affairs Medical Center - Houston
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San Antonio、Texas、美国、78229-3900
- University of Texas Health Science Center at San Antonio
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San Antonio、Texas、美国、78229
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple、Texas、美国、76504
- Veterans Affairs Medical Center - Temple
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Temple、Texas、美国、76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City、Utah、美国、84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City、Utah、美国、84112-5550
- Huntsman Cancer Institute
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Vermont
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Burlington、Vermont、美国、05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Richmond、Virginia、美国、23298-0037
- MBCCOP - Massey Cancer Center
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Washington
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Seattle、Washington、美国、98101
- CCOP - Virginia Mason Research Center
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Seattle、Washington、美国、98108
- Veterans Affairs Medical Center - Seattle
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Seattle、Washington、美国、98104
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Tacoma、Washington、美国、98431-5000
- Madigan Army Medical Center
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Tacoma、Washington、美国、98405-0986
- CCOP - Northwest
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed unresectable or metastatic gastrointestinal stromal tumor (GIST)
- Primary (gastrointestinal or intra-abdominal origin) tumor
At least 1 measurable lesion by x-ray, CT, MRI, ultrasound, or physical examination
- If lesions within prior radiation port are used as target lesions for response assessment, those lesions must have demonstrated clear progression after completion of radiotherapy
- No uterine or retroperitoneal sarcomas or non-intra-abdominal leiomyosarcomas
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC (white blood count) at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No medical or psychological conditions that would preclude study participation
- No major infection requiring systemic antibiotics
- No uncontrolled bacterial, viral, or fungal infection
No other prior malignancy within the past 5 years except:
- Adequately treated basal cell or squamous cell skin cancer
- Adequately treated stage I or II cancer in complete remission
- Carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 30 days since prior biologic therapy
- Prior imatinib mesylate as adjuvant therapy or for metastatic disease allowed
Chemotherapy:
- No prior chemotherapy for GIST
- At least 30 days since other prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy for GIST
- No concurrent radiotherapy for GIST
- Concurrent palliative radiotherapy for painful metastases (encompassing a total portal of no greater than 5 x 5 cm) allowed
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior major surgery and recovered
Other:
- At least 30 days since prior investigational drugs
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Temozolomide
200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.
|
200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Assess response (confirmed & unconfirmed, complete & partial response)
大体时间：3 years
|
3 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Toxicities
大体时间：3 years
|
3 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Mark M. Zalupski, MD、University of Michigan Rogel Cancer Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2000年4月1日
初级完成 (实际的)
2005年10月1日
研究完成 (实际的)
2005年10月1日
研究注册日期
首次提交
2000年5月2日
首先提交符合 QC 标准的
2003年1月26日
首次发布 (估计)
2003年1月27日
研究记录更新
最后更新发布 (估计)
2013年1月3日
上次提交的符合 QC 标准的更新
2013年1月2日
最后验证
2013年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.