Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015821
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2001-05-06
Brief Title:
Thalidomide in Treating Patients With Myelofibrosis
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study of Thalidomide as an Inhibitor of Angiogenesis in the Treatment of Myelofibrosis With Myeloid Metaplasia MMM
Status:
COMPLETED
Status Verified Date:
2013-10
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 myelofibrosis Thalidomide may stop the growth of myelofibrosis by stopping blood flow to the cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To investigate whether thalidomide a potent inhibitor of angiogenic and fibrogenic growth factors is an effective therapeutic agent in patients with MMM Specifically to assess whether thalidomide improves anemia andor organomegaly in patients with MMM
II To assess the effects of thalidomide on the myelofibrotic stroma with respect to microvascular architecture and angiogenesis collagen and reticulin deposition and the expression of the mediating growth factors bFGF TGF-b and PDGF and their respective receptors
OUTLINE This is a multicenter study
Patients receive oral thalidomide once daily for 1 year in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may receive 1 additional year of therapy
Patients are followed every 6 months until 5 years from study entry
I To investigate whether thalidomide a potent inhibitor of angiogenic and fibrogenic growth factors is an effective therapeutic agent in patients with MMM Specifically to assess whether thalidomide improves anemia andor organomegaly in patients with MMM
II To assess the effects of thalidomide on the myelofibrotic stroma with respect to microvascular architecture and angiogenesis collagen and reticulin deposition and the expression of the mediating growth factors bFGF TGF-b and PDGF and their respective receptors
OUTLINE This is a multicenter study
Patients receive oral thalidomide once daily for 1 year in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may receive 1 additional year of therapy
Patients are followed every 6 months until 5 years from study entry
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 |
|---|---|---|---|
| U10CA025224 | NIH | CTEP | httpsreporternihgovquickSearchU10CA025224 |
| NCI-2012-01853 | REGISTRY | None | None |
| CDR0000068367 | None | None | None |
| NCCTG-N9982 | None | None | None |
| N9982 | OTHER | None | None |
| N9982 | OTHER | None | None |