S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring adult acute monocytic leukemia (M5b), adult acute erythroid leukemia (M6), adult acute megakaryoblastic leukemia (M7), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed acute myeloid leukemia (AML) FAB M1-2 or M4-7 No blastic transformation of chronic myelogenous leukemia In first relapse after prior complete response Patients who relapsed after autologous or allogeneic bone marrow or peripheral blood stem cell transplantation are not eligible CD33 positive Prior myelodysplastic syndromes or secondary AML allowed Concurrent enrollment on SWOG-9007 (cytogenetics protocol) No clinical or documented CNS involvement with AML PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic WBC no greater than 30,000/mm^3 Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 1.5 times ULN Renal Not specified Cardiovascular No unstable cardiac arrhythmias No unstable angina Other HIV negative No other malignancy within the past 5 years except for the following: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer currently in complete remission Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior gemtuzumab ozogamicin for AML Chemotherapy Prior hydroxyurea to control high cell counts allowed Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other At least 4 weeks since prior investigational agents and recovered
Sites / Locations
- Alta Bates Comprehensive Cancer Center
- Mills-Peninsula Health Services
- Marin Cancer Institute at Marin General Hospital
- Sutter Health Western Division Cancer Research Group
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- California Pacific Medical Center - California Campus
- Phoebe Cancer Center at Phoebe Putney Memorial Hospital
- Piedmont Hospital
- CCOP - Atlanta Regional
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- WellStar Cobb Hospital
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Hematology Oncology Associates of Eastern Idaho
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Decatur Memorial Hospital Cancer Care Institute
- Veterans Affairs Medical Center - Hines
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Regional Cancer Center at Memorial Medical Center
- St. Francis Hospital and Health Centers
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas, P.A. - El Dorado
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Cancer Center of Kansas - Kingman
- Southwest Medical Center
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas, P.A. - Parsons
- Pratt Cancer Center of Kansas
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Cancer Center at Stormont-Vail Regional Health Center
- St. Francis Comprehensive Cancer Center
- Cancer Center of Kansas - Wellington
- Associates in Womens Health
- Cancer Center of Kansas, P.A.
- Cancer Center of Kansas, P.A. - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Wesley Medical Center
- Cancer Center of Kansas - Winfield
- Baton Rouge General Regional Cancer Center
- Mary Bird Perkins Cancer Center - Baton Rouge
- Louisiana State University Health Sciences Center - Monroe
- Cancer Center at Medical Center of Louisiana - New Orleans
- MBCCOP - LSU Health Sciences Center
- Tulane Cancer Center
- Veterans Affairs Medical Center - Shreveport
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- University of Mississippi Medical Center
- St. Francis Medical Center
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
- CCOP - Kansas City
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - St. Louis-Cape Girardeau
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Montana Cancer Consortium
- Deaconess Billings Clinic - Downtown
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Internal Medicine Associates of Bozeman
- St. James Community Hospital
- Big Sky Oncology
- Great Falls Clinic
- Sletten Regional Cancer Institute
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Eastern Montana Cancer Center
- Community Medical Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Montana Cancer Specialists at Montana Cancer Center
- Orange Regional Medical Center - Horton Campus
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Randolph Hospital
- Presbyterian Cancer Center at Presbyterian Hospital
- John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
- Wayne Memorial Hospital, Incorporated
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Annie Penn Cancer Center
- Rutherford Hospital
- Adena Regional Medical Center
- Cleveland Clinic Taussig Cancer Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Riverside Cancer Services
- Mount Carmel West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Grady Memorial Hospital
- Community Oncology Group - Independence
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Middletown Regional Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Mercy Medical Center Oncology Unit
- Community Hospital of Springfield and Clark County
- UVMC Cancer Care Center at Upper Valley Medical Center
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
- Cleveland Clinic - Wooster
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Tod Children's Hospital - Forum Health
- Genesis - Good Samaritan Hospital
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Institute of Oncology at Vilnius University
- Legacy Meridian Park Hospital
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- CCOP - Upstate Carolina
- Brooke Army Medical Center
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Cancer Therapy and Research Center
- University Hospital - San Antonio
- University of Texas Health Science Center at San Antonio
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute at University of Utah
- St. Joseph Hospital Community Cancer Center
- Olympic Hematology and Oncology
- Cancer Care Center at Skagit Valley Hospital
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Harborview Medical Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- Cancer Center at Southwest Washington Medical Center
- Central Washington Hospital
- Wenatchee Valley Clinic
- Welch Cancer Center