Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070109
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2003-10-03
Brief Title:
Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewings Family of Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study Of Trabectedin ET-743 Yondelis in Children With Recurrent Rhabdomyosarcoma Ewing Sarcoma or Nonrhabdomyosarcomatous Soft Tissue Sarcomas
Status:
COMPLETED
Status Verified Date:
2018-08
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 trabectedin works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewings family of tumors Drugs used in chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate in pediatric patients with recurrent or refractory soft tissue sarcomas or Ewings sarcoma family of tumors treated with ecteinascidin 743 trabectedin
II Determine the toxicity of this drug in these patients III Determine the pharmacokinetics of this drug in these patients
OUTLINE
Patients receive trabectedin IV over 3 hours on day 1 Treatment repeats every 21days for up to 26 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for up to 5 years
I Determine the response rate in pediatric patients with recurrent or refractory soft tissue sarcomas or Ewings sarcoma family of tumors treated with ecteinascidin 743 trabectedin
II Determine the toxicity of this drug in these patients III Determine the pharmacokinetics of this drug in these patients
OUTLINE
Patients receive trabectedin IV over 3 hours on day 1 Treatment repeats every 21days for up to 26 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for up to 5 years
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-2009-00357 | REGISTRY | None | None |
| CDR0000329999 | OTHER | None | None |
| COG-ADVL0221 | OTHER | None | None |
| U10CA098543 | NIH | Childrens Oncology Group | httpsreporternihgovquickSearchU10CA098543 |