Phase II Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, in Children and Young Adults With Refractory Solid Tumors
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
Estimated using the product-limit method of Kaplan and Meier.
From enrollment until disease progression, death because of treatment complications, resection of measurable tumor or last patient follow-up whichever is first, assessed up to 5 years
Children's Oncology Group
United States: Food and Drug Administration
|Children's Oncology Group||Arcadia, California 91006-3776|