DISEASE CHARACTERISTICS:
- 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) NOTE: *Measurable disease
required; measurable disease is defined as lesions measured in ≥ 1
dimension by CT scan or MRI; ascites, pleural effusions, bone marrow
disease, and lesions detectable only by bone scan not considered
measurable disease
- Refractory or recurrent disease with no known curative treatment options
PATIENT CHARACTERISTICS:
- 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®
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- 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 of CYP3A4, including
any of the following:
- Clarithromycin
- Troleandomycin
- Erythromycin
- Ketoconazole
- Itraconazole
- Fluconazole (doses > 3 mg/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
OBJECTIVES:
- Determine the response rate to ixabepilone in various strata of recurrent solid
malignant tumors of childhood and young adulthood, including all of the following:
- Embryonal or alveolar rhabdomyosarcoma
- Osteosarcoma
- Ewing's sarcoma/peripheral neuroectodermal tumor
- Synovial sarcoma or malignant peripheral nerve sheath tumor
- Wilms' tumor
- Neuroblastoma
- Determine the time to progression for each tumor stratum.
- Prospectively evaluate the feasibility and utility of automated volumetric tumor
measurement in patients with measurable pulmonary metastases, and descriptively compare
volumetric measurements to 1-dimensional (RECIST criteria) and 2-dimensional (WHO
criteria) measurements.
- Define and describe the toxicities of ixabepilone.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (Ewing's
sarcoma/ peripheral neuroectodermal tumor vs osteosarcoma vs alveolar or embryonal
rhabdomyosarcoma vs Wilms' tumor vs neuroblastoma vs synovial sarcoma/malignant peripheral
nerve sheath tumor).
Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days in the
absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Comments
There are no comments for this clinical trial.
Add a new comment