Cytarabine With or Without VNP40101M 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 myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4)
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed acute myeloid leukemia (AML) Any WHO classification, excluding acute promyelocytic leukemia At least 10% blasts by bone marrow aspirate and/or biopsy In first relapse after achieving a first complete response (CR) OR CR (with platelet count < 100,000/mm³ but ≥ 20,000/mm³ [transfusion independent for ≥ 7 consecutive days]) (CRp) that lasted ≥ 3 months but ≤ 24 months after completion of the initial induction regimen Relapse confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology, and/or histologically confirmed CNS or extramedullary disease PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST ≤ 3 times ULN Chronic hepatitis allowed Renal Creatinine ≤ 2.0 mg/dL Cardiovascular No myocardial infarction within the past 3 months No uncontrolled arrhythmias No uncontrolled congestive heart failure Pulmonary No severe chronic obstructive pulmonary disease No requirement for supplemental oxygen at rest Immunologic No uncontrolled active infection Infections that are controlled and under active treatment with antibiotics allowed No evidence of invasive fungal infection by blood or tissue cultures Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No clinical evidence of another active malignancy by tumor marker, pathology, or radiologic studies No other severe medical condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 12 hours since prior hydroxyurea Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No prior treatment while in first relapse except hydroxyurea No other concurrent standard or investigational treatment for AML No concurrent disulfiram (Antabuse®)
Sites / Locations
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center at UCLA
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- UCSF Comprehensive Cancer Center
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- University of Miami Sylvester Comprehensive Cancer Center
- Veterans Affairs Medical Center - Tampa (Haley)
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- University of Chicago Cancer Research Center
- American Health Network - North Meridian
- Greenebaum Cancer Center at University of Maryland Medical Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Nevada Cancer Institute
- New Mexico Cancer Care Alliance
- Roswell Park Cancer Institute
- New York Medical College
- Duke Comprehensive Cancer Center
- Brody School of Medicine at East Carolina University
- Riverside Methodist Hospital Cancer Care
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- Hollings Cancer Center at Medical University of South Carolina
- Vanderbilt-Ingram Cancer Center
- M.D. Anderson Cancer Center at University of Texas
- Cliniques Universitaires Saint-Luc
- U.Z. Gasthuisberg
- CHU Charleroi - Site Vesale
- Vancouver Hospital and Health Science Center
- Saint John Regional Hospital
- Memorial University of Newfoundland
- Capital District Health Authority Center for Clinical Research
- Ottawa Hospital Regional Cancer Centre - General Campus
- Princess Margaret Hospital
- Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
- Hopital Edouard Herriot
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
- CHR Hotel Dieu
- Hopital Haut Leveque
- Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
- Medizinische Universitaetsklinik I at the University of Cologne
- Universitaetsfrauenklinik Frankfurt
- Universitatsklinikum Heidelberg
- Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
- Klinikum der Universitaet Muenchen - Grosshadern Campus
- University Wurzburg
- Evaggelismos Hospital
- University of Patras Medical School
- University Medical Center Groningen
- Medical University of Gdansk
- Medical University of Lodz
- Centrum Onkologii Ziemi Lubelskiez
- Wojskowy Instytut Medyczny
- Institute of Haematology and Blood Transfusion
- Clinical Centre of Serbia
- Clinical Centre Nis
- Clinic Centre Novi Sad
- Birmingham Heartlands Hospital
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
- Leicester Royal Infirmary
- King's College Hospital
- Manchester Royal Infirmary
- University Hospital of Wales
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Induction therapy arm I
Induction therapy arm II
Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).