Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217386
Status:
COMPLETED
Last Update Posted:
2010-09-15
First Post:
2005-09-20
Brief Title:
Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Therapy of Early Stage Myelodysplastic Syndrome MDS With ATG and Etanercept
Status:
COMPLETED
Status Verified Date:
2010-09
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 Biological therapies such as anti-thymocyte globulin and etanercept may stimulate the immune system in different ways and stop cancer cells from growing Giving anti-thymocyte globulin together with etanercept may kill more cancer cells
PURPOSE This phase II trial is studying how well giving anti-thymocyte globulin together with etanercept works in treating patients with myelodysplastic syndromes
PURPOSE This phase II trial is studying how well giving anti-thymocyte globulin together with etanercept works in treating patients with myelodysplastic syndromes
Detailed Description:
OBJECTIVES
Determine the response rate in patients with low- or intermediate-1-risk myelodysplastic syndromes treated with anti-thymocyte globulin and etanercept
Correlate ex vivo and in vitro phenotypic cytogenetic and functional disease characteristics with in vivo response in patients treated with this regimen
Determine parameters that are associated with a high probability of response or non-response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive anti-thymocyte globulin IV over 8 hours on days 1-4 Patients also receive etanercept subcutaneously on days 8 11 15 and 18 Treatment with etanercept repeats every 28 days for at least 2 courses Patients exhibiting hematologic improvement after course 2 may receive up to 2 additional courses of etanercept in the absence of disease progression or unacceptable toxicity Patients with unresponsive disease or disease progression after course 2 are removed from the study and offered other treatment
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 3 years
Determine the response rate in patients with low- or intermediate-1-risk myelodysplastic syndromes treated with anti-thymocyte globulin and etanercept
Correlate ex vivo and in vitro phenotypic cytogenetic and functional disease characteristics with in vivo response in patients treated with this regimen
Determine parameters that are associated with a high probability of response or non-response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive anti-thymocyte globulin IV over 8 hours on days 1-4 Patients also receive etanercept subcutaneously on days 8 11 15 and 18 Treatment with etanercept repeats every 28 days for at least 2 courses Patients exhibiting hematologic improvement after course 2 may receive up to 2 additional courses of etanercept in the absence of disease progression or unacceptable toxicity Patients with unresponsive disease or disease progression after course 2 are removed from the study and offered other treatment
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| CDR0000430702 | REGISTRY | PDQ | None |
| FHCRC-187200 | None | None | None |