Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059904
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2003-05-06
Brief Title:
Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkins Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open-Labeled Phase II Study of Rituximab in Combination With Recombinant IL-2 for Relapsed or Refractory Non-Hodgkins Lymphoma of Intermediate- or High-Grade Histology
Status:
COMPLETED
Status Verified Date:
2004-07
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 Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Interleukin-2 may stimulate a persons white blood cells to kill cancer cells Combining rituximab with interleukin-2 may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining rituximab with interleukin-2 in treating patients who have relapsed or refractory intermediate- or high-grade non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combining rituximab with interleukin-2 in treating patients who have relapsed or refractory intermediate- or high-grade non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the clinical efficacy of rituximab and interleukin-2 in patients with relapsed or refractory intermediate- or high-grade non-Hodgkins lymphoma
Determine the 2-year progression-free survival of patients treated with this regimen
Determine the safety of this regimen in these patients
Correlate response with natural killer cell numbers and rituximab interleukin-2 IL-2 and soluble IL-2 receptor levels in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive rituximab IV once weekly on weeks 1-4 and interleukin-2 subcutaneously 3 times weekly on weeks 2-9 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 12 weeks for 2 years
PROJECTED ACCRUAL A total of 50-100 patients will be accrued for this study
Determine the clinical efficacy of rituximab and interleukin-2 in patients with relapsed or refractory intermediate- or high-grade non-Hodgkins lymphoma
Determine the 2-year progression-free survival of patients treated with this regimen
Determine the safety of this regimen in these patients
Correlate response with natural killer cell numbers and rituximab interleukin-2 IL-2 and soluble IL-2 receptor levels in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive rituximab IV once weekly on weeks 1-4 and interleukin-2 subcutaneously 3 times weekly on weeks 2-9 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 12 weeks for 2 years
PROJECTED ACCRUAL A total of 50-100 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000298986 | REGISTRY | PDQ Physician Data Query | None |
| MSKCC-03004 | None | None | None |