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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00331643 |
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.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer Neuroblastoma Sarcoma |
Drug: ixabepilone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, in Children and Young Adults With Refractory Solid Tumors |
Estimated Enrollment: | 120 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
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:
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.
Ages Eligible for Study: | 1 Year to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis (at original diagnosis or recurrence) of 1 of the following:
Wilms' tumor*
Neuroblastoma
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])
PATIENT CHARACTERISTICS:
No clinically significant unrelated systemic illness that would preclude study treatment, including any of the following:
PRIOR CONCURRENT THERAPY:
More than 1 week since prior and no concurrent strong inhibitors of CYP3A4, including any of the following:
More than 1 week since prior and no concurrent enzyme-inducing anticonvulsants, including any of the following:
Study Chair: | Brigitte C. Widemann, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000472912, COG-ADVL0524, NCI-06-C-0146, NCI-P6451 |
Study First Received: | May 30, 2006 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00331643 |
Health Authority: | United States: Food and Drug Administration |
alveolar childhood rhabdomyosarcoma childhood synovial sarcoma embryonal childhood rhabdomyosarcoma recurrent childhood rhabdomyosarcoma recurrent childhood soft tissue sarcoma previously treated childhood rhabdomyosarcoma recurrent neuroblastoma |
recurrent osteosarcoma recurrent adult soft tissue sarcoma adult rhabdomyosarcoma adult synovial sarcoma recurrent Wilms tumor and other childhood kidney tumors recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor |
Neuroectodermal Tumors, Primitive Ewing's family of tumors Malignant mesenchymal tumor Urogenital Neoplasms Kidney cancer Urologic Neoplasms Osteogenic sarcoma Neuroblastoma Soft tissue sarcomas Sarcoma, Synovial Neoplasms, Connective and Soft Tissue Ewing's sarcoma Sarcoma, Ewing's Urologic Diseases Kidney Neoplasms |
Neoplasms, Germ Cell and Embryonal Wilms Tumor Neuroepithelioma Kidney Diseases Rhabdomyosarcoma Epothilone B Epothilones Synovial sarcoma Wilms' tumor Osteosarcoma Renal cancer Recurrence Carcinoma Neuroectodermal Tumors Peripheral neuroectodermal tumor |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Neoplasms, Nerve Tissue Antimitotic Agents Neoplasms, Neuroepithelial Pharmacologic Actions |