Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022581
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2001-08-10
Brief Title:
Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Thalidomide NSC 66847 IND 48832 for Patients With Relapsed or Refractory Low Grade Non-Hodgkins Lymphoma
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 relapsed or refractory low-grade non-Hodgkins lymphoma Thalidomide may stop the growth of non-Hodgkins lymphoma by stopping blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the response rate and time-to-progression TTP in previously treated patients with low grade non-Hodgkins lymphoma treated with thalidomide
II To evaluate the effect of thalidomide on microvascular density in the bone marrow of patients with low grade cell non-Hodgkins lymphoma
III To evaluate the effects of thalidomide on bFGF levels in serum and urine
OUTLINE
Patients receive oral thalidomide once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 21-45 patients will be accrued for this study
I To estimate the response rate and time-to-progression TTP in previously treated patients with low grade non-Hodgkins lymphoma treated with thalidomide
II To evaluate the effect of thalidomide on microvascular density in the bone marrow of patients with low grade cell non-Hodgkins lymphoma
III To evaluate the effects of thalidomide on bFGF levels in serum and urine
OUTLINE
Patients receive oral thalidomide once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 21-45 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 |
|---|---|---|---|
| CDR0000068832 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-50002 | None | None | None |
| U10CA031946 | NIH | None | None |