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