Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia With FLT3/ITD Mutation; Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11; Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1; Acute Promyelocytic Leukemia With PML-RARA; FLT3 Gene Mutation; Therapy-Related Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Promyelocytic, Acute
Intervention: Biopsy; Bone Marrow Aspiration; Cytarabine; Daunorubicin Hydrochloride; Laboratory Biomarker Analysis; Quality-of-Life Assessment; Questionnaire Administration; Sorafenib Tosylate
Intervention description: Undergo biopsy; Undergo bone marrow aspirate; Given IV; Given IV; Correlative studies; Ancillary studies; Ancillary studies; Given PO
Intervention MeSH terms: Cytarabine; Sorafenib; Daunorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating
      older patients with acute myeloid leukemia (AML). Sorafenib tosylate may stop the growth of
      cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in
      chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to
      stop the growth of cancer cells, either by killing the cells or by stopping them from
      dividing. Giving sorafenib tosylate and combination chemotherapy may be an effective
      treatment for AML.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unequivocal histologic diagnosis of AML according to World Health Organization (WHO)
             criteria, EXCLUDING:

               -  Acute promyelocytic leukemia t(15;17)(q22;q12); promyelocytic leukemia
                  (PML)-retinoic acid receptor, alpha (RARA)

               -  Acute myeloid leukemia with t(8;21)(q22;q22); runt-related transcription factor 1
                  (RUNX1-RUNXT1) as determined by the Ohio State University (OSU) Molecular
                  Reference Laboratory, per CALGB 20202

               -  Acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16(p13.1;q22);
                  core-binding factor, beta subunit (CBFB)-myosin, heavy chain 11, smooth muscle
                  (MYH11) as determined by the OSU Molecular Reference Laboratory, per CALGB 20202

          -  AML patients with an antecedent hematologic disorder are eligible for treatment on
             this trial provided that they have not received chemotherapy, including lenalidomide,
             azacitidine or decitabine for their hematologic disorder; patients with
             therapy-related AML are eligible if there had been no further exposure to chemotherapy
             or radiation therapy for > 3 years and their primary malignancy is in remission

          -  FLT3 mutation (ITD or point mutation) determined by the OSU Molecular Reference
             Laboratory, per CALGB 20202

          -  No prior chemotherapy for AML with the following exceptions:

               -  Emergency leukapheresis

               -  Emergency treatment for hyperleukocytosis with hydroxyurea

               -  Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one
                  dose only)

               -  Growth factor/cytokine support

               -  All-trans retinoic acid (ATRA)