Last updated on August 2011

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Unspecified Childhood Solid Tumor | Leukemia | Protocol Specific
  • Age: Between 2 - 21 Years
  • Gender: Male or Female
  • Other:
    DISEASE CHARACTERISTICS:
    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
    PATIENT CHARACTERISTICS:
    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 μ/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 μ/L) (for the purpose of this study, the ULN
    for ALT is 45 μ/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
    PRIOR CONCURRENT THERAPY:
    See Disease Characteristics
    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 nonhematologic 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,
    pine, pelvis, ribs)
    At least 3 months since prior stem cell transplantation or rescue (for patients with
    olid 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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