Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030849
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2002-02-14
Brief Title:
Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial Of Oral Bexarotene Targretin Combined With Interferon Alfa-2b Intron-A For Patients With Cutaneous T-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2009-12
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Interferon alfa may interfere with the growth of cancer cells Combining chemotherapy with interferon alfa may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma
PURPOSE Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma
Detailed Description:
OBJECTIVES
Determine the response rate and response duration in patients with cutaneous T-cell lymphoma when treated with bexarotene and in the absence of a complete response interferon alfa
Determine the safety and toxicity in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral bexarotene once daily for 8 weeks
Patients with a complete response CR after 8 weeks continue bexarotene alone for at least another 8 weeks in the absence of unacceptable toxicity
Patients who progress or relapse during bexarotene therapy or who achieve less than a CR after 8 weeks begin receiving interferon alfa subcutaneously 3 times a week and oral bexarotene daily for at least another 8 weeks in the absence of continuing disease progression or unacceptable toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 20-45 patients will be accrued for this study within 2 years
Determine the response rate and response duration in patients with cutaneous T-cell lymphoma when treated with bexarotene and in the absence of a complete response interferon alfa
Determine the safety and toxicity in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral bexarotene once daily for 8 weeks
Patients with a complete response CR after 8 weeks continue bexarotene alone for at least another 8 weeks in the absence of unacceptable toxicity
Patients who progress or relapse during bexarotene therapy or who achieve less than a CR after 8 weeks begin receiving interferon alfa subcutaneously 3 times a week and oral bexarotene daily for at least another 8 weeks in the absence of continuing disease progression or unacceptable toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 20-45 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-2049 | None | None | None |
| MSKCC-01128 | None | None | None |