- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00005597
S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Alabama
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Mobile, Alabama, Forenede Stater, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006-2726
- CCOP - Western Regional, Arizona
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Phoenix, Arizona, Forenede Stater, 85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
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Tucson, Arizona, Forenede Stater, 85723
- Veterans Affairs Medical Center - Tucson
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Forenede Stater, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Forenede Stater, 91010
- City of Hope Comprehensive Cancer Center
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Long Beach, California, Forenede Stater, 90822
- Veterans Affairs Medical Center - Long Beach
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Los Angeles, California, Forenede Stater, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Forenede Stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Forenede Stater, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, Forenede Stater, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Forenede Stater, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Forenede Stater, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
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San Francisco, California, Forenede Stater, 94143-0128
- UCSF Comprehensive Cancer Center
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Santa Rosa, California, Forenede Stater, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Forenede Stater, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Forenede Stater, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Forenede Stater, 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, Forenede Stater, 20060
- MBCCOP - Howard University Cancer Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Forenede Stater, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, Forenede Stater, 96813
- MBCCOP - Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813-2424
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, Forenede Stater, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Forenede Stater, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Decatur, Illinois, Forenede Stater, 62526
- CCOP - Central Illinois
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Hines, Illinois, Forenede Stater, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Forenede Stater, 60153-5500
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160-7353
- University of Kansas Medical Center
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Wichita, Kansas, Forenede Stater, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Forenede Stater, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, Forenede Stater, 40502-2236
- Veterans Affairs Medical Center - Lexington
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Forenede Stater, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, Forenede Stater, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, Forenede Stater, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Forenede Stater, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Forenede Stater, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, Forenede Stater, 48109-0912
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Detroit, Michigan, Forenede Stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Forenede Stater, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, Forenede Stater, 49503
- CCOP - Grand Rapids
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Royal Oak, Michigan, Forenede Stater, 48073-6769
- CCOP - Beaumont
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Southfield, Michigan, Forenede Stater, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, Forenede Stater, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Forenede Stater, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Forenede Stater, 39216
- Veterans Affairs Medical Center - Jackson
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Missouri
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Kansas City, Missouri, Forenede Stater, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forenede Stater, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, Forenede Stater, 63110
- St. Louis University Health Sciences Center
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Springfield, Missouri, Forenede Stater, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Forenede Stater, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany, New York, Forenede Stater, 12208
- Veterans Affairs Medical Center - Albany
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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Rochester, New York, Forenede Stater, 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, Forenede Stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, Forenede Stater, 45267-0501
- Barrett Cancer Center
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Cleveland, Ohio, Forenede Stater, 44195-9001
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Forenede Stater, 43206
- CCOP - Columbus
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Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Forenede Stater, 45429
- CCOP - Dayton
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Toledo, Ohio, Forenede Stater, 43623-3456
- CCOP - Toledo Community Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Forenede Stater, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Forenede Stater, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Forenede Stater, 97201-3098
- Oregon Cancer Institute
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Charleston, South Carolina, Forenede Stater, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, Forenede Stater, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Forenede Stater, 29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38103
- University of Tennessee Cancer Institute
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Memphis, Tennessee, Forenede Stater, 38104
- Danville Radiation Therapy Center
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Texas
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Amarillo, Texas, Forenede Stater, 79106
- Harrington Cancer Center
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Amarillo, Texas, Forenede Stater, 79106
- Veterans Affairs Medical Center - Amarillo
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Dallas, Texas, Forenede Stater, 75216
- Veterans Affairs Medical Center - Dallas
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Fort Sam Houston, Texas, Forenede Stater, 78234-6200
- Brooke Army Medical Center
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Galveston, Texas, Forenede Stater, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, Forenede Stater, 77030
- Veterans Affairs Medical Center - Houston
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San Antonio, Texas, Forenede Stater, 78229-3900
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Forenede Stater, 78229
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, Forenede Stater, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, Forenede Stater, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Forenede Stater, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Forenede Stater, 84112-5550
- Huntsman Cancer Institute
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Vermont
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Burlington, Vermont, Forenede Stater, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Richmond, Virginia, Forenede Stater, 23298-0037
- MBCCOP - Massey Cancer Center
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Washington
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Seattle, Washington, Forenede Stater, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Forenede Stater, 98108
- Veterans Affairs Medical Center - Seattle
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Seattle, Washington, Forenede Stater, 98104
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Tacoma, Washington, Forenede Stater, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, Forenede Stater, 98405-0986
- CCOP - Northwest
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Assess response (confirmed & unconfirmed, complete & partial response)
Tidsramme: 3 years
|
3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Toxicities
Tidsramme: 3 years
|
3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Mark M. Zalupski, MD, University of Michigan Rogel Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer, bindevæv og blødt væv
- Neoplasmer efter histologisk type
- Neoplasmer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer, bindevæv
- Gastrointestinale stromale tumorer
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Temozolomid
Andre undersøgelses-id-numre
- CDR0000067710
- U10CA032102 (U.S. NIH-bevilling/kontrakt)
- S9926 (Anden identifikator: SWOG)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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-
Hospital Universitario Virgen de la ArrixacaIkke rekrutterer endnuLeversygdomme | Levertransplantation | Neoplasmer i leveren | Gastrointestinale stromale tumorer | Metastase | Levermetastaser | Levertransplantation; Komplikationer | Leverkræft | Levertransplantationslidelse | Leverkarcinom | GIST, ondartet | GIST | Metastaser | Metastatisk leverkræft | Gastrointestinal stromal tumor i... og andre forholdSpanien
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Kura Oncology, Inc.RekrutteringGastrointestinal stromal tumor (GIST) | Gastrointestinal stromal neoplasma | Gastrointestinal stromal tumor, ondartet | Gastrointestinal stromal cancer | Gastrointestinale stromalcelletumorerForenede Stater
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Centre Leon BerardRekrutteringMetastatisk gastrointestinal stromal tumor | Ikke-operabel gastrointestinal stromal tumor (GIST) | Lokalt avanceret gastrointestinal stromal tumor (GIST)Frankrig
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Joal BeaneIkke rekrutterer endnuMetastatisk gastrointestinal stromal tumor | Lokalt avanceret gastrointestinal stromal tumor | Ikke-operable ondartet gastrointestinal stromaltumor | Recurrent Gastrointestinal Stromal Tumor | Refractory Malignant Gastrointestinal Stromal TumorForenede Stater
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk gastrointestinal stromal tumor | Metastatisk sarkom | Lokalt avanceret sarkom | Lokalt avanceret gastrointestinal stromal tumor | Fase III gastrisk og omental gastrointestinal stromal tumor AJCC v8 | Stadie III tyndtarm, esophageal, kolorektal, mesenterisk og peritoneal gastrointestinal... og andre forholdForenede Stater
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Kumquat Biosciences Inc.RekrutteringGIST | Gastrointestinale tumorer | GIST - Gastrointestinal Stromal Tumor | Gastrointestinal stromal tumor | GIST Metastatisk kræftForenede Stater
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Centre Leon BerardRekrutteringC-KIT mutation | Metastatisk gastrointestinal stromal tumor (GIST) | Avanceret gastrointestinal stromal tumor (GIST)Frankrig
-
ARCAGY/ GINECO GROUPRoche Pharma AGAfsluttet
-
National Cancer Institute (NCI)RekrutteringMavekræft | Mave-neoplasma | Gastrointestinal stromal tumor (GIST) | Gastrointestinal stromal sarkom | Gastrointestinal stromal neoplasmaForenede Stater
-
Universität Duisburg-EssenIkke rekrutterer endnuGIST - Gastrointestinal Stromal Tumor | Gastrointestinal stromaltumor (GIST)Tyskland
Kliniske forsøg med temozolomide
-
The Cooper Health SystemGeorgetown University; University of Virginia; Virginia Commonwealth University og andre samarbejdspartnereIkke rekrutterer endnuGlioblastom | Astrocytom | Oligodendrogliom | Gliomer af høj grad
-
Bradmer Pharmaceuticals Inc.Afsluttet
-
Novartis PharmaceuticalsAfsluttetGlioblastomAustralien, Spanien, Canada, Forenede Stater
-
Activartis BiotechAfsluttet
-
AHS Cancer Control AlbertaAlberta Cancer FoundationRekrutteringGlioblastoma MultiformeCanada
-
Peking Union Medical College HospitalBeijing Tiantan Hospital; Tianjin Medical University General HospitalUkendtOndartede gliomerKina
-
Ruijin HospitalRekruttering
-
Merck Sharp & Dohme LLCAfsluttetKarcinom, ikke-småcellet lunge | Neoplasmer i hjernen | Metastaser, Neoplasma
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI); Schering-PloughAfsluttetLungekræftForenede Stater
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Fox Chase Cancer CenterNational Cancer Institute (NCI)AfsluttetLungekræftForenede Stater