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| Descriptive Information Fields | |||||
| Brief Title † | Ixabepilone in Treating Young Patients With Refractory Solid Tumors | ||||
| Official Title † | Phase II Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, in Children and Young Adults With Refractory Solid Tumors | ||||
| Brief Summary | RATIONALE: 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. PURPOSE: This phase II trial is studying how well ixabepilone works in treating young patients with refractory solid tumors. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Time to progression as measured by the product-limit method of Kaplan-Meier [ Designated as safety issue: No ] Progression-free survival at 6 months [ Designated as safety issue: No ] Response rates (complete response and partial response) [ Designated as safety issue: No ] Toxicity [ Designated as safety issue: Yes ] Correlate tumor burden and change in tumor burden by RECIST, WHO, and volumetric analysis [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Kidney Cancer Neuroblastoma Sarcoma |
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| Intervention † | Drug: ixabepilone | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 120 | ||||
| Start Date † | April 2006 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 1 Year to 35 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Australia, Canada, New Zealand | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00331643 | ||||
| Organization ID | CDR0000472912 | ||||
| Secondary IDs †† | COG-ADVL0524, NCI-06-C-0146, NCI-P6451 | ||||
| Study Sponsor † | Children's Oncology Group | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2007 | ||||
| First Received Date † | May 30, 2006 | ||||
| Last Updated Date | July 23, 2008 | ||||