Status:
COMPLETED
Ixabepilone in Treating Young Patients With Refractory Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Rhabdomyosarcoma
Adult Synovial Sarcoma
Eligibility:
All Genders
1-35 years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well ixabepilone works in treating young patients with refractory solid tumors. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the ...
Detailed Description
PRIMARY OBJECTIVES: I. 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00331643
Start Date
April 1 2006
End Date
June 1 2009
Last Update
November 14 2014
Active Locations (1)
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1
Children's Oncology Group
Arcadia, California, United States, 91006-3776