Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I Study of AR-42 and Decitabine in Acute Myeloid Leukemia
This phase I trial studies the side effects and best dose of AR-42 when given together with decitabine in treating patients with acute myeloid leukemia. AR-42 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving AR-42 together with decitabine may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To determine the biologic effective and tolerable dose (BETD) of AR-42 (histone
deacetylase [HDAC] inhibitor AR-42) in combination with a 10 day schedule of decitabine in
acute myeloid leukemia (AML) in adults (Stratum 1) and children (Stratum 2).
II. To define the specific toxicities and the dose limiting toxicity (DLT) of AR-42 in
combination with a 10 day schedule of decitabine in adults and children.
SECONDARY OBJECTIVES:
I. To describe biologic activity of the combination of AR-42 and decitabine (changes in micro
ribonucleic acid [RNA] [miR]-29b expression; specificity protein 1 [Sp1], deoxyribonucleic
acid [DNA] (cytosine-5-)-methyltransferase [DNMT]1, 3A and 3B, KIT and FMS-like tyrosine
kinase 3 [FLT3] RNA and protein levels).
II. To provide preliminary data for clinical response with the combination of AR-42 and
decitabine in adults and in children.
III. To provide preliminary data on correlation of biologic endpoints and clinical response
(particularly miR-29b expression).
OUTLINE: This is a dose-escalation study of HDAC inhibitor AR-42.
INDUCTION THERAPY: Patients receive HDAC inhibitor AR-42 orally (PO) daily on days 1, 3, and
5 or 1, 3, 4, 5 and decitabine intravenously (IV) over 1 hour on days 6-15. Treatment repeats
every 28 days for up to 3 courses in the absence of disease progression or unacceptable
toxicity.
MAINTENANCE THERAPY: Patients achieving complete remission (CR) or morphologic CR with
incomplete blood count recovery (CRi) receive HDAC inhibitor AR-42 as in Induction Therapy
and decitabine IV over 1 hour on days 6-10. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
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