Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Randomized Phase II Trial of Timed Sequential Cytosine Arabinoside (Ara-C) With and Without the Checkpoint Kinase 1 (CHK1) Inhibitor MK-8776 in Adults With Relapsed AML
This randomized phase II trial studies how well cytarabine with or without SCH 900776 works in treating adult patients with relapsed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. SCH 900776 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cytarabine is more effective with or without SCH 900776 in treating acute myeloid leukemia.
PRIMARY OBJECTIVES:
I. To compare the rates of complete remission (CR) plus CR with incomplete recovery (CRi)
achieved with cytosine arabinoside (ara-C) (cytarabine) plus the checkpoint kinase 1 (CHK1)
inhibitor MK-8776 (Chk1 inhibitor SCH 900776) vs. ara-C alone for adults (ages 18-75) with
relapsed acute myelogenous leukemia (AML).
SECONDARY OBJECTIVES:
I. To evaluate and compare the toxicities of ara-C + MK-8776 vs. ara-C alone. II. To
determine the disease free and overall survival of those achieving response to treatment.
III. To determine the impact of MK-8776 on AML blast cell deoxyribonucleic acid (DNA) repair
protein expression profiles and correlate the expression profiles with CR/CRi in response to
ara-C + MK-8776 vs. ara-C alone.
IV. To evaluate and compare the amount of DNA damage induced in AML blasts by ara-C +
MK-8776 vs. ara-C.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive cytarabine intravenously (IV) continuously over 72 hours on days 1-3
and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.
ARM B: Patients receive cytarabine as in Arm A.
In both arms, courses may repeat every 28 days.
After completion of study treatment, patients are followed up periodically.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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