Cytarabine With or Without SCH 900776 in Treating Adult Patients With Relapsed Acute Myeloid Leukemia
Condition: Adult Acute Megakaryoblastic Leukemia; Adult Acute Monoblastic Leukemia; Adult Acute Monocytic Leukemia; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With Maturation; Adult Acute Myeloid Leukemia With Minimal Differentiation; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL; Adult Acute Myeloid Leukemia Without Maturation; Adult Acute Myelomonocytic Leukemia; Adult Erythroleukemia; Adult Pure Erythroid Leukemia; Alkylating Agent-Related Acute Myeloid Leukemia; Recurrent Adult Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Cytarabine; CHK1 Inhibitor SCH 900776; Laboratory Biomarker Analysis
Intervention type(s): Drug; Drug; Other
Intervention description(s): Given IV; Given IV; Correlative studies
Other intervention name(s): CHX-3311; U-19920; SCH 900776
Intervention MeSH terms: Cytarabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment