NCT00331643

Ixabepilone in Treating Young Patients With Refractory Solid Tumors

Phase II Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, in Children and Young Adults With Refractory Solid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 1 Year – 35 Years
• Healthy volunteers: Not accepted

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 growth of tumor cells, either by killing the cells or by stopping them from dividing.

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 alveolar rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma/peripheral neuroectodermal tumor, synovial sarcoma or malignant peripheral nerve sheath tumor, Wilms' tumor, and neuroblastoma. II. Determine the time to progression for each tumor stratum. III. 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. IV. 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 up every year for 5 years. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	ixabepilone	Given IV

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-10-01
• Completion: 2009-06-01
• First posted: 2006-05-31
• Last updated: 2014-11-14

Locations

1 site across 1 country: United States