Ixabepilone in Treating Young Patients With Refractory Solid Tumors

Inclusion Criteria:

* Histologically confirmed diagnosis (at original diagnosis or recurrence) of 1 of the following:

  * Embryonal or alveolar rhabdomyosarcoma
  * Osteosarcoma\*
  * Ewing's sarcoma /peripheral neuroectodermal tumor\*
  * Synovial sarcoma or malignant peripheral nerve sheath tumor\*
  * Wilms' tumor\*

    * Age ≤ 21 years at original diagnosis
  * Neuroblastoma

    * Age ≤ 21 years at original diagnosis
    * Clinically or radiographically measurable or evaluable (by iodine I 123 metaiodobenzoguanine sulfate \[\^123I-MIBG\] or bone scan \[evaluable tumors must be positive at ≥ 1 site\])

      * If lesion was previously irradiated, a biopsy must be performed ≥ 6 weeks after completion of radiotherapy and viable neuroblastoma must be demonstrated
      * No elevated urinary catecholamines and/or bone marrow evidence of tumor with measurable disease clinically or by imaging modalities (CT scan, MRI, \^123I-MIBG, or bone scan)
* Refractory or recurrent disease with no known curative treatment options
* ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100% (patients \> 16 years of age) OR Lansky PS 50-100% (patients ≤ 16 years)
* Life expectancy ≥ 8 weeks
* No evidence of active graft-versus-host disease
* Absolute neutrophil count ≥ 1,500/mm³ (no growth factors)
* Platelet count ≥ 75,000/mm³ (transfusion independent)
* Not pregnant or nursing
* Fertile patients must agree to use effective contraception
* Negative pregnancy test
* Hemoglobin ≥ 8 g/dL (may receive RBC transfusions)
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 2.5 times ULN
* No clinically significant unrelated systemic illness that would preclude study treatment, including any of the following:

  * Serious infections
  * Hepatic, renal, or other organ dysfunction
  * CNS toxicity ≤ grade 2
  * No pre-existing sensory or motor neuropathy ≥ grade 2
* Seizure disorder allowed provided it is well controlled by anticonvulsants
* No known prior severe hypersensitivity reaction to agents containing Cremophor EL®
* Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
* More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks if prior nitrosourea)
* At least 7 days since prior biologic agents
* At least 2 weeks since prior local palliative (small-port) radiotherapy
* At least 6 months since prior craniospinal radiotherapy OR radiotherapy to ≥ 50% of the pelvis
* At least 6 weeks since other prior substantial bone marrow radiotherapy
* At least 4 months since prior allogeneic stem cell transplant (SCT)
* At least 2 months since prior autologous SCT
* No prior taxane (paclitaxel, docetaxel) therapy
* More than 1 week since prior growth factor use (except epoetin alfa)
* More than 1 week since prior and no concurrent strong inhibitors ofCYP3A4, including any of the following:

  * Clarithromycin
  * Troleandomycin
  * Erythromycin
  * Ketoconazole
  * Itraconazole
  * Fluconazole (doses \> 3mg/kg/day)
  * Voriconazole
  * Nefazodone
  * Fluvoxamine
  * Verapamil
  * Diltiazem
  * Amiodarone
  * Grapefruit juice
* More than 1 week since prior and no concurrent enzyme-inducing anticonvulsants, including any of the following:

  * Carbamazepine
  * Felbamate
  * Phenobarbital
  * Phenytoin
  * Primidone
  * Oxcarbazepine
* No concurrent aprepitant
* No concurrent Hypericum perforatum (St. John's wort)
* No concurrent sargramostim (GM-CSF) or interleukin-11
* No other concurrent chemotherapy or immunomodulating agents
* No concurrent radiotherapy
* Concurrent steroids allowed for pain or chemotherapy-associated nausea or vomiting