Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005853
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
2000-06-02
Brief Title:
Biological Therapy in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Therapy of Myelodysplastic Syndrome MDS With Antithymocyte Globulin ATG and TNFRFc
Status:
COMPLETED
Status Verified Date:
2010-03
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 use different ways to stimulate the immune system and stop cancer cells from growing Combining different types of biological therapies may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of biological therapy in treating patients who have myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of biological therapy in treating patients who have myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine the frequency of hematologic responses in patients with myelodysplastic syndrome treated with anti-thymocyte globulin and tumor necrosis factor receptor IgG chimera
Correlate phenotypic cytogenetic and functional disease characteristics with treatment responses in these patients
Determine the safety of this treatment regimen in this patient population
OUTLINE Patients receive anti-thymocyte globulin IV over 8 hours daily for 4 days followed by tumor necrosis factor receptor IgG chimera subcutaneously twice weekly for 16 weeks
Patients are followed at 8 16 and 20 weeks
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
Determine the frequency of hematologic responses in patients with myelodysplastic syndrome treated with anti-thymocyte globulin and tumor necrosis factor receptor IgG chimera
Correlate phenotypic cytogenetic and functional disease characteristics with treatment responses in these patients
Determine the safety of this treatment regimen in this patient population
OUTLINE Patients receive anti-thymocyte globulin IV over 8 hours daily for 4 days followed by tumor necrosis factor receptor IgG chimera subcutaneously twice weekly for 16 weeks
Patients are followed at 8 16 and 20 weeks
PROJECTED ACCRUAL A total of 15 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 |
|---|---|---|---|
| FHCRC-147800 | None | None | None |
| NCI-G00-1793 | None | None | None |
| CDR0000067878 | REGISTRY | PDQ | None |