Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia

Inclusion Criteria:

   - Diagnosis of 1 of the following:

      - Histologically confirmed malignant solid tumor at original diagnosis or relapse

         - Measurable or evaluable disease by CT scan or MRI

      - Histologically confirmed leukemia, including 1 of the following:

         - Acute lymphoblastic leukemia (ALL)

            - Greater than 25% blasts in the bone marrow (M3 bone marrow)

         - Acute myeloid leukemia (AML)

            - Greater than 25% blasts in the bone marrow (M3 bone marrow)

         - AML and FLT3-ITD mutation

            - Patients must have ? 5% blasts in the bone marrow

            - Active extramedullary disease (except leptomeningeal disease) allowed

         - Juvenile myelomonocytic leukemia (JMML) meeting the following criteria:

            - Peripheral blood monocytosis > 1,000/mm^3

            - Blasts (including promonocytes) are < 20% of the WBCs in the blood and
            of the nucleated bone marrow cells

            - No Philadelphia chromosome (Ph) or BCR/ABL fusion gene

            - Has ? 2 of the following additional diagnostic criteria:

               - Hemoglobin F increased for age

               - Immature granulocytes in the peripheral blood

               - WBC > 10,000/mm^3

               - Clonal chromosomal abnormality (e.g., may be monosomy 7)

               - Sargramostim (GM-CSF) hypersensitivity of myeloid progenitors in
               vitro

         - Chronic myelogenous leukemia (CML) in blast crisis

            - Greater than 25% blasts in the bone marrow (M3 bone marrow)

            - Patients with Ph-positive CML must be refractory to imatinib mesylate

   - Relapsed or refractory disease

      - Patients with acute promyelocytic leukemia (APL) must be refractory to treatment
      with tretinoin and arsenic trioxide

   - Standard curative therapies or therapies proven to prolong survival with an acceptable
   quality of life do not exist

   - Active extramedullary disease, except active leptomeningeal leukemia, allowed

   - No brain tumors or known brain metastases

   - Karnofsky performance status (PS) 50-100% (for patients > 10 years of age)

   - Lansky PS 50-100% (for patients ? 10 years of age)

   - Patients with solid tumors must have adequate bone marrow function, as defined by the
   following:

      - Absolute neutrophil count ? 1,000/mm^3

      - Platelet count ? 75,000/mm^3 (transfusion independent)

      - Hemoglobin ? 8.0 g/dL (red blood cell [RBC] transfusions allowed)

   - Patients with leukemia may have abnormal blood counts but must meet the following
   criteria:

      - Platelet count ? 20,000/mm^3 (platelet transfusions allowed)

      - Hemoglobin ? 8.0 g/L (RBC transfusions allowed)

   - Patients with acute myeloid leukemia and FLT3-ITD mutation

      - Platelet count ? 20,000/mm^3

   - Lipase and amylase normal

   - Creatinine clearance or radioisotope glomerular filtration rate ? 70 mL/min OR
   creatinine normal based on age as follows:

      - No greater than 0.8 mg/dL (for patients 5 years of age and under)

      - No greater than 1.0 mg/dL (for patients 6-10 years of age)

      - No greater than 1.2 mg/dL (for patients 11-15 years of age)

      - No greater than 1.5 mg/dL (for patients over 15 years of age)

   - Patients with solid tumors must meet the following criteria:

      - Bilirubin normal for age

      - ALT normal for age (for the purpose of this study, the upper limit of normal
      [ULN] for ALT is 45 ?/L)

      - Serum albumin ? 2 g/dL

   - Patients with leukemia must meet the following criteria:

      - Bilirubin (sum of conjugated + unconjugated) ? 1.5 times ULN for age

      - ALT ? 5.0 times ULN for age (? 225 ?/L) (for the purpose of this study, the ULN
      for ALT is 45 ?/L)

      - Serum albumin ? 2 g/dL

   - Albumin ? 2 g/dL

   - PT, PTT, and INR normal (for patients on prophylactic anticoagulation)

   - No evidence of dyspnea at rest

   - No exercise intolerance

   - Pulse oximetry >94% on room air, if there is clinical indication for determination

   - Diastolic blood pressure ? the 95th percentile for age and gender (height included for
   AML and FLT3-ITD mutation patients)

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception

   - No uncontrolled infection

   - Able to swallow tablets

   - No evidence of bleeding diathesis

   - No other medical condition or situation that would preclude study compliance

   - No known Gilbert syndrome

   - Fully recovered from prior chemotherapy, immunotherapy, or radiotherapy (for patients
   with solid tumors)

   - Recovered from the non-hematologic toxic effects of all prior therapy (for patients
   with leukemia)

   - Recovered from acute non-hematologic toxic effects of all prior anti-cancer
   chemotherapy (for patients with AML and FLT3-ITD mutation)

   - At least 7 days since prior hematopoietic growth factors

   - At least 7 days since prior biologic agents

   - At least 2 weeks since prior local palliative radiotherapy (small port)

   - At least 3 months since prior total-body irradiation, craniospinal radiotherapy, or
   radiation to ? 50% of the pelvis

   - At least 6 weeks since other prior substantial bone marrow radiation (e.g., skull,
   spine, pelvis, ribs)

   - At least 3 months since prior stem cell transplantation or rescue (for patients with
   solid tumors)

      - No evidence of active graft-vs-host disease

   - At least 3 months since prior myeloablative therapy followed by bone marrow or stem
   cell transplantation (for patients with leukemia)

   - At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
   (for patients with solid tumors)

      - At least 24 hours since prior nitrosoureas (for patients with AML and FLT3-ITD
      mutation)

   - At least 2 weeks since prior chemotherapy (for patients with leukemia)

   - At least 3 weeks since prior monoclonal antibody therapy

   - No prior sorafenib

   - No other concurrent investigational drugs

   - No other concurrent anticancer agents or therapies, including chemotherapy,
   radiotherapy, immunotherapy, or biologic therapy

      - Concurrent maintenance-like chemotherapy for patients with AML and FLT3-ITD
      mutation allowed

   - No concurrent administration of any of the following:

      - Cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin,
      carbamazepine, or phenobarbital)

      - Rifampin

      - Grapefruit juice

      - Hypericum perforatum (St. John wort)

   - No concurrent therapeutic anticoagulation

      - Concurrent prophylactic anticoagulation (e.g., low-dose warfarin) of venous or
      arterial access devices allowed provided the requirements for PT, INR, or PTT are
      met