Sorafenib Tosylate in Treating Younger Patients With Relapsed or Refractory Rhabdomyosarcoma, Wilms Tumor, Liver Cancer, or Thyroid Cancer

Inclusion Criteria

• Patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse:
• Rhabdomyosarcoma (RMS)
• Wilms tumor
• Hepatocellular carcinoma (HCC)
• Papillary thyroid carcinoma (PTC)
• Patients must have relapsed or refractory disease (RMS, Wilms tumor, HCC, PTC)
• Patients must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm)
• The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium, or positron emission tomography [PET] scans)
• Elevated tumor markers in plasma or cerebrospinal fluid(CSF)
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the requirements noted above
• Patients with HCC must be relapsed or refractory to conventional chemotherapy
• Patients with PTC must be refractory to radioactive iodine (RAI)
• Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
• Patients with known metastasis to the brain will be excluded from trial participation unless treated surgically or with radiotherapy and stable with no recurrent lesions for at least 3 months
• Rhabdomyosarcoma and Wilms strata: patients must be ≥ 24 months and ≤ 30 years of age at study enrollment
• Hepatocellular carcinoma (HCC): patients must be ≥ 24 months and 16 years of age and Lansky for patients ≤ 16 years of age
• Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL
• Platelet count ≥ 75, 000/μL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment)
• Hemoglobin 8.0 g/dL (may receive red blood cell[RBC] transfusions)
• Creatinine clearance or radioisotope glomerular filtration rate(GFR) 70 mL/min OR a serum creatinine based on age/gender as follows:
• 0.8 mg/dL (2 to 94% if there is clinical indication for determination
• A blood pressure (BP) ≤ the 95^th percentile for age, height, and gender; and not receiving medication for treatment of hypertension
• Patients who are pregnant or breast-feeding are not eligible
• Negative pregnancy tests must be obtained in girls who are post-menarchal
• Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method beginning at the signing of the informed consent until at least 30 days after the last dose of the study drug
• Patients with clinical symptoms of hepatic encephalopathy or ascites are not eligible
• Patients who have an uncontrolled infection are not eligible
• Patients with evidence of bleeding diathesis are not eligible
• Patients with known Gilbert syndrome are not eligible
• Patients who, in the opinion of the investigator, may not be able to comply with the safety-monitoring requirements of the study are not eligible
• No concurrent chemotherapy, radiation therapy, immunomodulating agents, or other investigational agents
• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
• Patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
• At least 7 days must have elapsed since the completion of therapy with a growth factor (