Clinical trial NCT00331643 (phase 2, status: completed)
Conditions: adult rhabdomyosarcoma, adult synovial sarcoma, alveolar childhood rhabdomyosarcoma, childhood synovial sarcoma, embryonal childhood rhabdomyosarcoma, previously treated childhood rhabdomyosarcoma, recurrent adult soft tissue sarcoma, recurrent childhood rhabdomyosarcoma, recurrent childhood soft tissue sarcoma, recurrent ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent neuroblastoma, recurrent osteosarcoma, recurrent wilms tumor and other childhood kidney tumors
ICD codes: M67.20, M67.211, M67.212, M67.219, M67.231, M67.232, M67.239, F80.81, F84.3, F93.8, F93.9, R62.0, E71.520, F64.2, F80.81, F84.3, F93.8, F93.9, R62.0, E71.520, F64.2, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: ixabepilone
SMILES: [H][C@]12C[C@H](NC(=O)C[C@H](O)C(C)(C)C(=O)[C@H](C)[C@@H](O)[C@@H](C)CCC[C@@]1(C)O2)C(\C)=C\C1=CSC(C)=N1
Eligibility criteria:

        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