| Inclusion Criteria: | 1) Patients must be >/= 12 months old at trial entry. Patients with neuroblastoma or Wilms tumor must have been </= 21 years of age when originally diagnosed with the malignancy to be treated on this protocol. All other patients must have been </= 35 years of age when originally diagnosed with the malignancy to be treated on this protocol.
2) All entry/eligibility studies must be performed within 1 week prior to entry onto the trial (unless otherwise specified). Imaging studies are required within 2 weeks of study entry.
3) The date protocol therapy is projected to start must be no later than five calendar days after the date of study enrollment. Patients who are started on protocol therapy on a Phase II study prior to registration will not be entered on study.
4) Patients must have had histologic verification of the malignancy at original diagnosis or at recurrence.
5) The patient must have a histological diagnosis of one of the target tumors: Embryonal or alveolar rhabdomyosarcoma; Osteosarcoma; Ewing's sarcoma/Peripheral neuroectodermal tumor (PNET); Synovial sarcoma or malignant peripheral nerve sheath tumor (MPNST); Wilms tumor; or, Neuroblastoma.
6) All patients must have refractory or recurrent tumors with no known curative treatment options.
7) For patients with sarcoma and Wilms tumor: Patients must have measurable disease. Measurable disease is defined as lesions that can be measured in at least one dimension by medical imaging techniques (CT or MRI scan). Ascites, pleural effusions, bone marrow disease, and lesions detectable only by bone scan will not be considered measurable disease.
8) For patients with neuroblastoma: Patients with either clinically or radiographically measurable disease or evaluable disease by I-MIBG or bone scan are eligible. For evaluable tumor, I-MIBG or bone scan must be positive at a minimum of one site.
9) For patients with neuroblastoma: If the lesion was previously radiated, a biopsy must be done at least 6 weeks after radiation is complete and demonstrate viable neuroblastoma.
10) Patients must have an ECOG performance status of 0, 1 or 2, or Karnofsky >/= 50% (patients > 16 years of age) or Lansky >/= 50% (patients </= 16 years).
11) Patients must have a life expectancy of >/= 8 weeks.
12) Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
13) Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea).
14) Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent.
15) XRT: >/= 2 wks for local palliative XRT (small port); >/= 6 months must have elapsed if prior craniospinal XRT or if >/= 50% radiation of pelvis; >/= 6 wks must have elapsed if other substantial BM radiation.
16) Stem Cell Transplant (SCT): No evidence of active graft vs. host disease. For allogeneic SCT, >/= 4 months must have elapsed; for autologous SCT >/= 2 months must have elapsed.
17) Study specific limitations on prior therapy: Patients may not have received prior taxane (paclitaxel, docetaxel) therapy.
18) Concomitant Medications Restrictions: No other cancer chemotherapy, radiation therapy or immunomodulating agents will be used. However, steroids may be used for the treatment and prevention of hypersensitivity reactions and as clinically indicated, for example, for the treatment of pain or chemotherapy associated nausea or vomiting, if necessary.
19) Growth factor(s): Must not have received within 1 week of entry onto this study, with the exception of erythropoietin.
20) Study Specific: Patients may not be currently receiving strong inhibitors of CYP3A4, and may not have received these medications within 1 week of entry.
21) Patients may not be taking enzyme–inducing anticonvulsants, and may not have received these medications within 1 week of entry, as these patients may experience different drug disposition. These medications include: Carbamazepine (Tegretol); Felbamate (Felbtol); Phenobarbital; Phenytoin (Dilantin); Primidone (Mysoline); Oxcarbazepine (Trileptal).
22) All patients must have adequate bone marrow function defined as: Peripheral absolute neutrophil count (ANC) >/= 1500/microL (off growth factors); platelet count >/= 75,000/microL (transfusion independent); and, hemoglobin >/= 8 gm/dL (may receive RBC transfusions).
23) Adequate renal function defined as: Creatinine clearance or radioisotope GFR >/= 70 ml/min/1.73 m^2; OR, 2) maximum serum creatinine (md/dL) based on age/gender as follows: Estimated Creatinine Clearance (in mL/min/1.73 m^2): 1 month to < 6 months: 0.4 md/dL; 6 months to < 1 yr: 0.5 md/dL; 1 to < 2 yrs: 0.6 md/dL; 2 to < 6 yrs: 0.8 md/dL; 6 to < 10 yrs: 1 md/dL; 10 to < 13 yrs: 1.2 md/dL; 13 to < 16 yrs: Male: 1.5 md/dL; Female: 1.4 md/dL; >/= 16 yrs: Male: 1.7 md/dL; Female: 1.4 mg/dL.
24) All patients must have adequate liver function defined As: Total bilirubin </= 1.5 x upper limit of normal (ULN) for age; and SGPT (ALT) </= 110 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
25) All patients must have nervous system function defined as: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled. Enzyme inducing anticonvulsant drugs are not allowed on this trial; CNS toxicity </= Grade 2; and, existing sensory or motor neuropathy must be grade </= 1.
26) All patients and/or their parents or legal guardians must sign a written informed consent.
27) All institutional, FDA, and NCI requirements for human studies must be met. |