Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005625
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-05-02
Brief Title:
Ecteinascidin 743 in Treating Patients With Previously Treated Metastatic Osteosarcoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Study of ET-743 Therapy in Metastatic Osteosarcoma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have previously treated metastatic osteosarcoma
PURPOSE Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have previously treated metastatic osteosarcoma
Detailed Description:
OBJECTIVES I Determine the partial and complete response rate in patients with previously treated metastatic osteosarcoma when treated with ecteinascidin 743 II Further characterize the toxicity profile and the pharmacokinetic-pharmacodynamic relationships of this drug in this patient population
OUTLINE This is a multicenter study Patients receive ecteinascidin 743 IV over 24 hours Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression for at least 2-6 courses Patients with a complete response CR receive at least 2 additional courses after documented CR Patients are followed every 3 months until disease progression All patients are followed until death after disease progression
PROJECTED ACCRUAL A total of 25-33 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive ecteinascidin 743 IV over 24 hours Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression for at least 2-6 courses Patients with a complete response CR receive at least 2 additional courses after documented CR Patients are followed every 3 months until disease progression All patients are followed until death after disease progression
PROJECTED ACCRUAL A total of 25-33 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 |
|---|---|---|---|
| CDR0000067769 | REGISTRY | None | None |
| PMAR-ET-019-99 | None | None | None |
| NCI-G00-1761 | Registry Identifier | PDQ Physician Data Query | None |