Ixabepilone in Treating Young Patients With Refractory Solid Tumors
Completed · Phase 2
Conditions studied: 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
In brief
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 growth of tumor cells, either by killing the cells or by stopping them from dividing.
Key facts
- Study ID
- NCT00331643
- Run by
- National Cancer Institute (NCI)
- People needed
- 120
- Starts
- 2006-04-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2014-11-14
Who can join
Age: 1 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Children's Oncology Group — Arcadia, California, United States
Full record on ClinicalTrials.gov
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