Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003615
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Denileukin Diftitox in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Study of DAB 389 IL-2 an Interleukin-2 Fusion Toxin for Previously Treated Stage II III and IV Follicular Low-Grade Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-06
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 Immunotoxins such as denileukin diftitox can locate cancer cells and kill them without harming normal cells This may be an effective treatment for non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have non-Hodgkins lymphoma that has not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have non-Hodgkins lymphoma that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the objective response rate in patients with previously treated stage I II III or IV low- or intermediate-grade B-cell non-Hodgkins lymphoma treated with denileukin diftitox II Determine the time to progression duration of remission and time to treatment failure in patients after treatment with this therapy III Determine the toxicity of this therapy in these patients IV Correlate the results of the inteleukin-2 receptor assay with treatment outcomes in these patients
OUTLINE Patients are stratified according to interleukin-2 receptor classification positive vs negative Patients receive immunotoxin therapy with denileukin diftitox IV over 15-60 minutes on days 1-5 Treatment repeats every 21 days for 2-6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 33 patients will be accrued for the interleukin-2 IL-2 receptor-positive stratum and a total of 11-44 patients will be accrued for the IL-2 receptor-negative stratum
OUTLINE Patients are stratified according to interleukin-2 receptor classification positive vs negative Patients receive immunotoxin therapy with denileukin diftitox IV over 15-60 minutes on days 1-5 Treatment repeats every 21 days for 2-6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 33 patients will be accrued for the interleukin-2 IL-2 receptor-positive stratum and a total of 11-44 patients will be accrued for the IL-2 receptor-negative stratum
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 |
|---|---|---|---|
| E1497 | None | None | None |