Sunitinib in Treating Young Patients With Refractory Solid Tumors

Inclusion Criteria:

* Histologically confirmed solid tumor (not required for patients with intrinsic brain stem tumors or optic pathway gliomas)

  * Recurrent or refractory disease
* Measurable or evaluable disease
* No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
* Patients with metastatic bone marrow disease are eligible but are not evaluable for hematologic toxicity

  * Must not be refractory to red blood cell or platelet transfusions
* Primary CNS tumors or known CNS metastases allowed

  * Neurological deficits must have been relatively stable for ≥ 1 week before study enrollment
  * No imaging evidence of prior intracranial hemorrhage
  * No evidence of new CNS hemorrhage on baseline MRI obtained within 14 days before study enrollment (ECHO gradient MRI sequences per institutional guidelines required for evaluation of CNS hemorrhage)

    * The presence of small punctuate CNS hemorrhage on these scans will exclude a patient from participation
* No known bone marrow metastatic disease
* No tumors involving the pleural surface
* Karnofsky performance status (PS) 50-100% (\> 10 years of age) OR Lansky PS 50-100% (≤ 10 years of age)
* Absolute neutrophil count ≥ 1,000/mm³\*
* Platelet count ≥ 100,000/mm³ (transfusion independent)\*
* Hemoglobin ≥ 8.0 g/dL (transfusions allowed)\*
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age/gender as follows:

  * No greater than 0.8 mg/dL (2 to 5 years of age)
  * No greater than 1 mg/dL (6 to 9 years of age)
  * No greater than 1.2 mg/dL (10 to 12 years of age)
  * No greater than 1.5 mg/dL (male) OR 1.4 mg/dL (female) (13 to 15 years of age)
  * No greater than 1.7 mg/dL (male) OR 1.4 mg/dL (female) (≥ 16 years of age)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases)
* Albumin ≥ 2 g/dL
* LVEF or shortening fraction normal
* Corrected QT interval ≤ 450 msec
* Amylase ≤ 1.5 times ULN
* Lipase ≤ 1.5 times ULN
* Body surface area ≥ 0.5 m² (≥ 0.4 m² for part B)
* Blood pressure within ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No uncontrolled infection
* Able to swallow sunitinib malate capsules (part A only)
* No pre-existing thyroid abnormality (hyper- or hypothyroidism) with unstable thyroid function
* No prior CNS hemorrhage
* No history of allergic reaction attributed to sunitinib malate or component of sunitinib malate capsules
* No allergy to both applesauce and yogurt (part B only)
* Recovered from prior therapy
* No prior sunitinib malate
* No prior anthracycline (any dose)
* No prior radiotherapy to a radiation field that included the heart(including total body or craniospinal irradiation)
* At least 3 months since prior stem cell transplantation or rescue (without total-body irradiation) and no evidence of graft-vs-host disease
* At least 2 weeks since prior local, palliative, small-port radiotherapy (at least 6 months for radiation to ≥ 50% of pelvis)
* At least 6 weeks since other prior substantial bone marrow radiotherapy
* At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosoureas)
* At least 1 week since prior antineoplastic biologic agents
* At least 1 week since prior and no concurrent hematopoietic growth factors
* At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:

  * Rifampin
  * Rifabutin
  * Carbamazepine
  * Phenobarbital
  * Phenytoin
  * Hypericum perforatum (St. John's wort)
  * Efavirenz
  * Tipranavir
* At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:

  * Azole antifungals (e.g., itraconazole or ketoconazole)
  * Clarithromycin
  * Erythromycin
  * Diltiazem
  * Verapamil
  * HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir)
  * Delavirdine
* No more than 1 concurrent antihypertensive agent
* No concurrent major surgery
* No concurrent antithrombotic or antiplatelet agents, including any of the following:

  * Warfarin
  * Heparin
  * Low molecular weight heparin
  * Acetylsalicylic acid (aspirin)
  * Ibuprofen
  * Other nonsteroidal anti-inflammatory drugs
* No concurrent medication for the treatment of hypertension
* No other concurrent investigational drugs
* No other concurrent anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy