Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082914
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2004-05-14
Brief Title:
Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Status:
COMPLETED
Status Verified Date:
2005-12
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 Denileukin diftitox may be able to make the body build an immune response to kill tumor cells
PURPOSE This phase II trial is studying how well denileukin diftitox works in treating patients with metastatic melanoma or metastatic kidney cancer
PURPOSE This phase II trial is studying how well denileukin diftitox works in treating patients with metastatic melanoma or metastatic kidney cancer
Detailed Description:
OBJECTIVES
Primary
Determine the clinical response in patients with metastatic melanoma or metastatic kidney cancer treated with denileukin diftitox
Secondary
Determine whether changes occur in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood of these patients before and after treatment with this drug
Determine the toxicity profile of this drug in these patients
OUTLINE Patients are stratified according to disease type metastatic melanoma vs metastatic kidney cancer
Patients receive denileukin diftitox IV over 1 hour on days 1-5 21-25 42-46 and 63-67 Treatment repeats every 84 days 12 weeks for up to a maximum total of 5 courses in the absence of disease progression autoimmune ocular toxicity attributable to denileukin diftitox or any other unacceptable toxicity At any time during therapy patients achieving a complete response receive 1 additional course of therapy after the complete response
PROJECTED ACCRUAL A total of 10-96 patients 5-48 per stratum will be accrued for this study within 3-4 years
Primary
Determine the clinical response in patients with metastatic melanoma or metastatic kidney cancer treated with denileukin diftitox
Secondary
Determine whether changes occur in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood of these patients before and after treatment with this drug
Determine the toxicity profile of this drug in these patients
OUTLINE Patients are stratified according to disease type metastatic melanoma vs metastatic kidney cancer
Patients receive denileukin diftitox IV over 1 hour on days 1-5 21-25 42-46 and 63-67 Treatment repeats every 84 days 12 weeks for up to a maximum total of 5 courses in the absence of disease progression autoimmune ocular toxicity attributable to denileukin diftitox or any other unacceptable toxicity At any time during therapy patients achieving a complete response receive 1 additional course of therapy after the complete response
PROJECTED ACCRUAL A total of 10-96 patients 5-48 per stratum will be accrued for this study within 3-4 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-04-C-0134 | None | None | None |