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