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