Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006345
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2000-10-04
Brief Title:
Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma
Sponsor:
Ligand Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Evaluation of Corticosteroid Pretreatment in Cutaneous T-Cell Lymphoma Patients Receiving Ontak Denileukin Difitox
Status:
COMPLETED
Status Verified Date:
2001-11
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 Denileukin diftitox may be able to deliver cancer-killing substances directly to T-cell lymphoma cells Dexamethasone may decrease the side effects of denileukin diftitox
PURPOSE Phase II trial to study the effectiveness of dexamethasone in preventing side effects following treatment with denileukin diftitox in treating patients who have persistent or recurrent T-cell lymphoma
PURPOSE Phase II trial to study the effectiveness of dexamethasone in preventing side effects following treatment with denileukin diftitox in treating patients who have persistent or recurrent T-cell lymphoma
Detailed Description:
OBJECTIVES I Evaluate the potential benefit of dexamethasone administered prior to denileukin diftitox in terms of avoidance andor reduction of hypersensitivity type reactions flu-like symptom complex and vascular leak syndrome side effects adverse events in patients with persistent or recurrent cutaneous T-cell lymphoma II Assess the response rate in terms of tumor burden reduction in these patients treated with this regimen III Determine the rate of patient withdrawal from the study due to adverse effects
OUTLINE This is an open label multicenter study Patients receive denileukin diftitox IV over 30-60 minutes on days 1-5 Patients also receive oral dexamethasone twice daily beginning 24 hours prior to and concomitantly with denileukin diftitox Treatment continues every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 2 or 4 weeks
PROJECTED ACCRUAL Approximately 15-30 patients will be accrued for this study
OUTLINE This is an open label multicenter study Patients receive denileukin diftitox IV over 30-60 minutes on days 1-5 Patients also receive oral dexamethasone twice daily beginning 24 hours prior to and concomitantly with denileukin diftitox Treatment continues every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 2 or 4 weeks
PROJECTED ACCRUAL Approximately 15-30 patients will be accrued for this study
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-V00-1614 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068169 | REGISTRY | None | None |