Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015990
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2001-05-06
Brief Title:
Thalidomide in Treating Patients With Myelodysplastic Syndrome
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Thalidomide in the Treatment of Myelodysplastic Syndromes in Adults A Clinical and Biologic Study
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase II trial to study the effectiveness of thalidomide in treating patients who have myelodysplastic syndrome Thalidomide may improve the immune systems ability to fight myelodysplastic syndrome
Detailed Description:
OBJECTIVES
I Determine whether thalidomide improves cytopenias in patients with myelodysplastic syndromes
II Determine the toxicity of this regimen in these patients III Determine whether this regimen down regulates the peripheral blood levels of tumor necrosis factor alpha interferon gamma and interleukin-12 and whether these changes correlate with clinical response in these patients
IV Determine whether this regimen alters the peripheral blood T-cell subset distribution and whether these changes correlate with clinical response in these patients
V Determine the effect of this regimen on bone marrow microvessel density and whether these effects correlate with clinical response in these patients
OUTLINE This is a multicenter study Patients are stratified according to prognosis favorable vs unfavorable Favorable stratum closed to accrual 122801
Patients receive oral thalidomide once daily Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 1 year and then annually for 4 years
PROJECTED ACCRUAL A total of 20-58 patients 10-29 per stratum will be accrued for this study within 20 months Favorable stratum closed to accrual 122801
I Determine whether thalidomide improves cytopenias in patients with myelodysplastic syndromes
II Determine the toxicity of this regimen in these patients III Determine whether this regimen down regulates the peripheral blood levels of tumor necrosis factor alpha interferon gamma and interleukin-12 and whether these changes correlate with clinical response in these patients
IV Determine whether this regimen alters the peripheral blood T-cell subset distribution and whether these changes correlate with clinical response in these patients
V Determine the effect of this regimen on bone marrow microvessel density and whether these effects correlate with clinical response in these patients
OUTLINE This is a multicenter study Patients are stratified according to prognosis favorable vs unfavorable Favorable stratum closed to accrual 122801
Patients receive oral thalidomide once daily Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 1 year and then annually for 4 years
PROJECTED ACCRUAL A total of 20-58 patients 10-29 per stratum will be accrued for this study within 20 months Favorable stratum closed to accrual 122801
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 |
|---|---|---|---|
| CDR0000068580 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA025224 |
| N998B | None | None | None |
| U10CA025224 | NIH | None | None |