Spots Global Cancer Trial Database for S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia
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Trial Identification
Brief Title: S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia
Official Title: A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)
Study ID: NCT00049179
Conditions
Study Description
Brief Summary: RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with cytarabine in treating patients who have relapsed acute myeloid leukemia.
Detailed Description: OBJECTIVES: * Determine the safety and efficacy of gemtuzumab ozogamicin and cytarabine in patients with relapsed acute myeloid leukemia. * Determine the frequency and severity of toxic effects of this regimen in CD33-positive patients. * Determine, preliminarily, the prognostic significance of drug resistance phenotype, cytogenetics, and molecular genetic characteristics of patients treated with this regimen. OUTLINE: This is a multicenter study. * Induction: Patients receive gemtuzumab ozogamicin IV over at least 2 hours on days 1 and 8 and cytarabine IV continuously over days 1-7. * Consolidation: Beginning between days 28 and 75, patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status receive one course of gemtuzumab ozogamicin and cisplatin as in induction chemotherapy. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years. PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 10-28 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
Mills-Peninsula Health Services, Burlingame, California, United States
Marin Cancer Institute at Marin General Hospital, Greenbrae, California, United States
Sutter Health Western Division Cancer Research Group, Greenbrae, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, United States
California Pacific Medical Center - California Campus, San Francisco, California, United States
Phoebe Cancer Center at Phoebe Putney Memorial Hospital, Albany, Georgia, United States
Piedmont Hospital, Atlanta, Georgia, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
Northside Hospital Cancer Center, Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta, Atlanta, Georgia, United States
WellStar Cobb Hospital, Austell, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center, Decatur, Georgia, United States
Gwinnett Medical Center, Lawrenceville, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital, Marietta, Georgia, United States
Southern Regional Medical Center, Riverdale, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
Hematology Oncology Associates of Eastern Idaho, Idaho Falls, Idaho, United States
Saint Anthony's Hospital at Saint Anthony's Health Center, Alton, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines, Hines, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States
St. Francis Hospital and Health Centers, Beech Grove, Indiana, United States
Cancer Center of Kansas - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado, El Dorado, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Cancer Center of Kansas - Kingman, Kingman, Kansas, United States
Southwest Medical Center, Liberal, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons, Parsons, Kansas, United States
Pratt Cancer Center of Kansas, Pratt, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Salina Regional Health Center, Salina, Kansas, United States
Cancer Center at Stormont-Vail Regional Health Center, Topeka, Kansas, United States
St. Francis Comprehensive Cancer Center, Topeka, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
Associates in Womens Health, Wichita, Kansas, United States
Cancer Center of Kansas, P.A., Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Wesley Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
Baton Rouge General Regional Cancer Center, Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana, United States
Louisiana State University Health Sciences Center - Monroe, Monroe, Louisiana, United States
Cancer Center at Medical Center of Louisiana - New Orleans, New Orleans, Louisiana, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Tulane Cancer Center, New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
St. Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Gape Girardeau, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
CCOP - St. Louis-Cape Girardeau, St. Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy, St. Louis, Missouri, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Deaconess Billings Clinic - Downtown, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
St. Vincent Healthcare, Billings, Montana, United States
Deaconess Billings Clinic Cancer Center, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Internal Medicine Associates of Bozeman, Bozeman, Montana, United States
St. James Community Hospital, Butte, Montana, United States
Big Sky Oncology, Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Sletten Regional Cancer Institute, Great Falls, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Eastern Montana Cancer Center, Miles City, Montana, United States
Community Medical Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Orange Regional Medical Center - Horton Campus, Middletown, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Randolph Hospital, Asheboro, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital, Eden, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital, Greensboro, North Carolina, United States
Annie Penn Cancer Center, Reidsville, North Carolina, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grant Riverside Cancer Services, Columbus, Ohio, United States
Mount Carmel West Hospital, Columbus, Ohio, United States
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital, Dayton, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Cancer Care Center, Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Community Oncology Group - Independence, Independence, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
Middletown Regional Hospital, Middletown, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
Mercy Medical Center Oncology Unit, Springfield, Ohio, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital, Westerville, Ohio, United States
Cleveland Clinic - Wooster, Wooster, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Tod Children's Hospital - Forum Health, Youngstown, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
Legacy Mount Hood Medical Center, Glesham, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center, Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Institute of Oncology at Vilnius University, Portland, Oregon, United States
Legacy Meridian Park Hospital, Tualatin, Oregon, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center, Anderson, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, United States
Cancer Therapy and Research Center, San Antonio, Texas, United States
University Hospital - San Antonio, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States
St. Joseph Hospital Community Cancer Center, Bellingham, Washington, United States
Olympic Hematology and Oncology, Bremerton, Washington, United States
Cancer Care Center at Skagit Valley Hospital, Mt. Vernon, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Group Health Central Hospital, Seattle, Washington, United States
Harborview Medical Center, Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Cancer Center at Southwest Washington Medical Center, Vancouver, Washington, United States
Central Washington Hospital, Wenatchee, Washington, United States
Wenatchee Valley Clinic, Wenatchee, Washington, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Contact Details
Name: John E. Godwin, MD, MS
Affiliation: Loyola University
Role: STUDY_CHAIR
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