Gemcitabine and Mitoxantrone 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 minimally differentiated myeloid leukemia (M0), 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 monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7)
Eligibility Criteria
DISEASE CHARACTERISTICS: Bone marrow examination or peripheral blood analysis confirming active acute myeloid leukemia by WHO criteria No M3 acute myeloid leukemia Not a candidate for allogenic bone marrow transplantation Patient must be in first relapse after having received induction chemotherapy Received 1 or 2 courses with remission lasting at least 1 month Patients with chloromas or leukemia cutis are eligible No evidence of leptomeningeal involvement PATIENT CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Liver enzymes (total bilirubin, aspartate aminotransferase (AST) and ALT) ≤ 2.5 times the upper limits of normal Liver enzymes ≥ 2.5 are acceptable if physician documents that it is secondary to the disease Serum creatinine ≤ 3 mg/dL No poorly controlled medical conditions that would seriously complicate compliance with this study No other active primary malignancy other than carcinoma in situ of the cervix or basal cell carcinoma of the skin No New York Heart Association grade III or IV cardiac problems, defined as congestive heart failure or myocardial infarction within 6 months prior to start of study Pregnant or nursing women are ineligible Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No documented history of human immunodeficiency virus (HIV) infection No history of chronic liver disease Ejection fraction ≥ 45% No significant history of non-compliance to medical regimens or inability to give reliable informed consent PRIOR CONCURRENT THERAPY: Previous treatment related toxicities should be resolved to grade 1 or better No other investigational agents within 14 days prior to the start of study No chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to start of study No major surgery within 2 weeks prior to start of study At least two weeks must have elapsed since the conclusion of radiation therapy and the start of gemcitabine hydrochloride, provided the acute effects of radiation treatment have been resolved
Sites / Locations
- Duke Comprehensive Cancer Center
- Cleveland Clinic Taussig Cancer Center
Arms of the Study
Arm 1
Experimental
Gemcitabine + Mitoxantrone
Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.