Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006039
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-07-05
Brief Title:
Interferon Alfa-2b in Treating Patients With Advanced Low-Grade Non-Hodgkins Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Study of Weekly Administered High-Dose Pegylated Interferon Alfa-2B PEGIntron in Advanced Stage Low Grade Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 Interferon alfa may interfere with the growth of the cancer cells and slow the growth of non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of interferon alfa-2b in treating patients who have advanced low-grade non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of interferon alfa-2b in treating patients who have advanced low-grade non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the response in patients with minimally treated or previously untreated advanced low-grade non-Hodgkins lymphoma treated with pegylated interferon alfa-2b II Determine the effects of this treatment regimen on the immune system by measuring T-cell subsets and NK cells in this patient population III Determine event-free and progression-free survival in this patient population treated with this regimen IV Evaluate the toxicity profile of this treatment regimen in these patients
OUTLINE Patients receive pegylated interferon alfa-2b subcutaneously once weekly for 6 months in the absence of disease progression or unacceptable toxicity Upon completion of treatment patients are followed every 6 months for at least 2 years
PROJECTED ACCRUAL A total of 30 patients will be initially accrued for this study Additional patients will be accrued if acceptable responses are seen in the first cohort
OUTLINE Patients receive pegylated interferon alfa-2b subcutaneously once weekly for 6 months in the absence of disease progression or unacceptable toxicity Upon completion of treatment patients are followed every 6 months for at least 2 years
PROJECTED ACCRUAL A total of 30 patients will be initially accrued for this study Additional patients will be accrued if acceptable responses are seen in the first cohort
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 |
|---|---|---|---|
| NCI-G00-1814 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068054 | REGISTRY | None | None |