Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015912
Status:
TERMINATED
Last Update Posted:
2013-01-25
First Post:
2001-05-06
Brief Title:
Interferon Alfa Plus 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 Clinical And Biologic Study Of The Combination Of Low Dose Interferon-Alpha And Thalidomide NSC 66847 For Patients With Relapsed Or Refractory Low-Grade Follicular Lymphoma
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
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 combining thalidomide with interferon alfa in treating patients who have relapsed or refractory non-Hodgkins lymphoma Thalidomide may stop the growth of cancer by stopping blood flow to the tumor Interferon alfa may interfere with the growth of cancer cells Combining thalidomide with interferon alfa may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the efficacy of interferon alfa and thalidomide in terms of response rate time to progression and overall survival in patients with relapsed or refractory low-grade follicular non-Hodgkins lymphoma
II Determine the quantitative and qualitative toxic effects of this regimen in this patient population
III Correlate ancillary biological studies with clinical endpoints in these patients treated with this regimen
OUTLINE
Patients receive interferon alfa subcutaneously every 12 hours and oral thalidomide daily in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months until disease progression
I Determine the efficacy of interferon alfa and thalidomide in terms of response rate time to progression and overall survival in patients with relapsed or refractory low-grade follicular non-Hodgkins lymphoma
II Determine the quantitative and qualitative toxic effects of this regimen in this patient population
III Correlate ancillary biological studies with clinical endpoints in these patients treated with this regimen
OUTLINE
Patients receive interferon alfa subcutaneously every 12 hours and oral thalidomide daily in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months until disease progression
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 |
|---|---|---|---|
| CDR0000068572 | REGISTRY | PDQ Physician Data Query | None |
| 00-171 CWRU 5Y99 | None | None | None |