Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed 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 myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute megakaryoblastic leukemia (M7), secondary acute myeloid leukemia, adult acute monocytic leukemia (M5b), adult acute minimally differentiated myeloid leukemia (M0)
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven acute myelogenous leukemia (AML) that may have been primary AML, secondary AML, or preceded by hematologic disorder All FAB subtypes except M3 Must meet one of the following three criteria: First relapse within 1 year after documentation of a previous complete remission (CR) achieved by chemotherapy Refractory to prior chemotherapy comprised of a minimum of 1 induction course, including cytarabine at a minimum of 500 mg/m2 (e.g., 100 mg/m2/day for 5 days) plus an anthracycline No high dose cytarabine (no cumulative dose greater than 3 g/m2) First relapse from a previous CR with subsequent autologous bone marrow transplantation (BMT), only if all of the following criteria are met: First BMT At least 100 days but less than 1 year posttransplantation At least 25% cellularity of the bone marrow Previous BMT included full hematopoietic recovery, defined by all of the following: Hemoglobin at least 10 g/dL (without transfusion) Platelet count at least 100,000/mm3 (without transfusion) Absolute neutrophil count at least 1,500/mm3 No transplantation candidates Bone marrow blasts (leukemic cells) greater than 10% No chronic myelogenous leukemia in blast crisis No active CNS leukemia PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration) SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML) Renal: Creatinine less than 2.0 mg/dL (unless related to AML) Cardiovascular: Left ventricular function normal No unstable cardiac arrhythmias, unstable angina pectoris, or myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No electrocardiogram evidence of active ischemia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study HIV negative No other active malignancy requiring therapy No active serious infection that is uncontrolled by antimicrobial therapy Medically stable No significant organ dysfunction PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 30 days since prior experimental biologic therapy (e.g., interleukin-2) No concurrent biologic therapy, including bone marrow transplantation Chemotherapy: See Disease Characteristics For first relapse AML with recent or prior chemotherapy: Prior hydroxyurea given as a short course (up to 48 hours) allowed, if needed, to reduce the peripheral leukocyte count Hydroxyurea must be discontinued prior to study For refractory AML with recent or prior chemotherapy: Greater than 2 weeks since prior chemotherapy except hydroxyurea given as above No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental therapy Concurrent therapy for other preexisting diseases allowed
Sites / Locations
- USC/Norris Comprehensive Cancer Center
- Jonsson Comprehensive Cancer Center, UCLA
- Beckman Research Institute, City of Hope
- St. Joseph Hospital - Orange
- Sutter Cancer Center
- University of California Davis Cancer Center
- Sidney Kimmel Cancer Center
- Washington Cancer Institute
- Emory Clinic
- University of Illinois at Chicago
- Loyola University Medical Center
- University of Iowa Hospitals and Clinics
- Louisiana State University School of Medicine
- Johns Hopkins Oncology Center
- New England Medical Center Hospital
- Massachusetts General Hospital Cancer Center
- Dana-Farber Cancer Institute
- Beth Israel Deaconess Medical Center
- West Michigan Cancer Center
- North Mississippi Hematology and Oncology Associates, Ltd.
- Washington University Barnard Cancer Center
- Nevada Cancer Center
- Cancer Institute of New Jersey
- Albert Einstein Comprehensive Cancer Center
- Roswell Park Cancer Institute
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Presbyterian Hospital - Cornell Campus
- New York Medical College
- Lineberger Comprehensive Cancer Center, UNC
- Duke Comprehensive Cancer Center
- Akron General Medical Center
- Ireland Cancer Center
- Cleveland Clinic Taussig Cancer Center
- Milton S. Hershey Medical Center
- University of Pennsylvania Cancer Center
- University of Pittsburgh Medical Center
- West Clinic, P.C.
- Vanderbilt University Medical Center
- Medical College of Wisconsin
- Algemeen Ziekenhuis Middelheim
- Institut Jules Bordet
- U.Z. Gasthuisberg
- Cross Cancer Institute
- Health Sciences Centre
- Queen Elizabeth II Health Science Center
- Princess Margaret Hospital
- Centre Hospitalier Regional et Universitaire d'Angers
- CHRU de Nancy - Hopitaux de Brabois
- Universitaetsklinikum Benjamin Franklin
- Klinikum der J.W. Goethe Universitaet
- Klinikum Rechts Der Isar/Technische Universitaet Muenchen
- Westfaelische Wilhelms-Universitaet
- University of Rostock
- Academisch Medisch Centrum
- Addenbrooke's NHS Trust
- Royal Free Hospital
- Leeds Teaching Hospital Trust
- Christie Hospital N.H.S. Trust