Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute promyelocytic leukemia (M3), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute megakaryoblastic leukemia (M7), adult acute monocytic leukemia (M5b), adult acute minimally differentiated myeloid leukemia (M0)
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven acute myelogenous leukemia of one of the following types: Acute myeloblastic leukemia (FAB type M0, M1, or M2) Acute promyelocytic leukemia (FAB type M3) allowed if ineligible for an ECOG M3 protocol or if no tretinoin or arsenic trioxide therapy is planned Acute myelomonocytic leukemia (FAB type M4) Acute monocytic leukemia (FAB type M5) Acute erythroleukemia (FAB type M6) Acute megakaryocytic leukemia (FAB type M7) Must meet 1 of the following criteria: Relapse less than 6 months after first complete remission (CR) Relapse 6-12 months after first CR Refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course) Must have marrow documentation of residual leukemia after chemotherapy (for at least 2 weeks duration) Second or greater relapse No relapse greater than 1 year after achieving first CR Blast cells must be CD33 positive Prior CNS leukemia allowed if there is currently documentation of no CNS involvement on CSF examination (i.e., negative CSF by lumbar puncture) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL* SGOT less than 2 times upper limit of normal* NOTE: *Unless due to leukemia infiltration Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: See Chemotherapy No myocardial infarction within the past 3 months No significant congestive heart failure No significant cardiac arrhythmia Cardiac ejection fraction normal by MUGA scan or echocardiogram Resting ejection fraction at least 50% or at least 5% increase with exercise Shortening fraction at least 24% or normal by echocardiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent organ damage or other medical problems that would precludestudy therapy No concurrent evidence (including positive blood or deep tissue cultures or stains) of invasive fungal infection No hypersensitivity to ingredients of gemtuzumab ozogamicin or daunorubicin liposomal No other active tumor that would interfere with study therapy or increase risk PRIOR CONCURRENT THERAPY: Biologic therapy: No prior gemtuzumab ozogamicin Chemotherapy: See Disease Characteristics See Biologic therapy No prior daunorubicin liposomal or topotecan Prior doxorubicin (no greater than 300 mg/m2), daunorubicin (no greater than 300 mg/m2), idarubicin (no greater than 100 mg/m2), or mitoxantrone (no greater than 100 mg/m2) allowed if left ventricular function is adequate At least 4 weeks since prior chemotherapy except patients who are refractory to conventional initial induction chemotherapy Prior hydroxyurea allowed within 4 weeks prior to beginning study Hydroxyurea must be discontinued at least 24 hours prior to beginning study Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy except patients who are refractory to conventional initial induction chemotherapy Surgery: Not specified
Sites / Locations
- CCOP - Scottsdale Oncology Program
- Cancer Center and Beckman Research Institute, City of Hope
- Veterans Affairs Medical Center - Palo Alto
- Stanford University Medical Center
- CCOP - Colorado Cancer Research Program, Inc.
- CCOP - Christiana Care Health Services
- Veterans Affairs Medical Center - Gainsville
- Veterans Affairs Medical Center - Miami
- H. Lee Moffitt Cancer Center and Research Institute
- Veterans Affairs Medical Center - Tampa (Haley)
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- Veterans Affairs Medical Center - Lakeside Chicago
- CCOP - Central Illinois
- CCOP - Evanston
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- Indiana University Cancer Center
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Holden Comprehensive Cancer Center at The University of Iowa
- MBCCOP - LSU Health Sciences Center
- CCOP - Ochsner
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- New England Medical Center Hospital
- Beth Israel Deaconess Medical Center
- CCOP - Ann Arbor Regional
- CCOP - Kalamazoo
- CCOP - Duluth
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Veterans Affairs Medical Center - Omaha
- CCOP - Missouri Valley Cancer Consortium
- CCOP - Southern Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - East Orange
- CCOP - Northern New Jersey
- Cancer Institute of New Jersey
- Albert Einstein Comprehensive Cancer Center
- MBCCOP-Our Lady of Mercy Cancer Center
- Veterans Affairs Medical Center - Brooklyn
- Veterans Affairs Medical Center - New York
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- University of Rochester Cancer Center
- CCOP - Merit Care Hospital
- Ireland Cancer Center
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- CCOP - Toledo Community Hospital Oncology Program
- CCOP - Oklahoma
- Hahnemann University Hospital
- University of Pennsylvania Cancer Center
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- University of Pittsburgh Cancer Institute
- Veterans Affairs Medical Center - Pittsburgh
- CCOP - MainLine Health
- CCOP - Sioux Community Cancer Consortium
- Veterans Affairs Medical Center - Madison
- University of Wisconsin Comprehensive Cancer Center
- CCOP - Marshfield Medical Research and Education Foundation
- MBCCOP - San Juan
- Veterans Affairs Medical Center - San Juan
- Pretoria Academic Hospitals