Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331643
Status:
COMPLETED
Last Update Posted:
2014-11-14
First Post:
2006-05-30
Brief Title:
Ixabepilone in Treating Young Patients With Refractory Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Ixabepilone BMS-247550 an Epothilone B Analog in Children and Young Adults With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Ewings sarcomaperipheral 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 Ewings sarcoma peripheral neuroectodermal tumor vs osteosarcoma vs alveolar or embryonal rhabdomyosarcoma vs Wilms tumor vs neuroblastoma vs synovial sarcomamalignant 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
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 Ewings sarcomaperipheral 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 Ewings sarcoma peripheral neuroectodermal tumor vs osteosarcoma vs alveolar or embryonal rhabdomyosarcoma vs Wilms tumor vs neuroblastoma vs synovial sarcomamalignant 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01826 | REGISTRY | None | None |
| COG-ADVL0524 | None | None | None |
| CDR0000472912 | None | None | None |
| NCI-P6451 | None | None | None |
| NCI-06-C-0146 | None | None | None |
| ADVL0524 | OTHER | None | None |
| ADVL0524 | OTHER | None | None |
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |