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This phase I clinical trial is studying the side effects and best dose of azacitidine when given together with mitoxantrone, etoposide phosphate, and cytarabine in treating patients with relapsed or refractory acute myeloid leukemia. Azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone, etoposide phosphate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may help mitoxantrone, etoposide phosphate, and cytarabine work better by making cancer cells more sensitive to the drugs.
I. To determine the maximum-tolerated dose of azacitidine when combined with salvage chemotherapy comprising mitoxantrone hydrochloride, etoposide phosphate, and cytarabine (MEC) in patients with relapsed or refractory acute myeloid leukemia (AML).
I. To define the qualitative and quantitative toxicities of azacitidine in combination with MEC with regard to organ specificity, time course, predictability, and reversibility.
II. To document the rate of complete remission (CR) and CR with incomplete blood count recovery (CRi) in patients treated with this combination of agents.
III. To determine the overall survival, relapse-free survival, and event-free survival of patients treated with this combination of agents.
IV. To evaluate the pharmacokinetics of azacitidine when given in combination with MEC in patients enrolled on this study. (Exploratory) V. To measure R2 down regulation, including changes in R2 target, AraCTP, and dNTP/NTP pools, of azacitidine when given in combination with MEC and to correlate these pharmacodynamic endpoints with clinical response. (Exploratory) VI. To evaluate hypomethylation, including DMNT1 expression, Sp1 expression, global DNA methylation, gene expression profiling, and microRNA expression profiling, of azacitidine when given in combination with MEC and to correlate these pharmacodynamic changes with clinical response. (Exploratory)
OUTLINE: This is a dose-escalation study of azacitidine.
Patients receive azacitidine IV over 30 minutes on days 1-8 and mitoxantrone hydrochloride IV over 10 minutes, etoposide phosphate IV over 30-60 minutes, and cytarabine IV over 6 hours on days 3-8 in the absence of disease progression or unacceptable toxicity. Treatment may repeat every 8 days for 1 additional course. Blood and bone marrow samples are collected at baseline and periodically during study for pharmacokinetic and pharmacodynamic studies.
After completion of study therapy, patients are followed up for 30 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Azacitidine, Cytarabine, Etoposide, Laboratory Biomarker Analysis, Mitoxantrone Hydrochloride, Pharmacological Study
Ohio State University Comprehensive Cancer Center
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2015-04-28T14:38:24-0400
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