Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278369
Status:
COMPLETED
Last Update Posted:
2013-05-22
First Post:
2006-01-16
Brief Title:
Pilot Study of Denileukin Diftitox Plus High-Dose IL-2 for Patients With Metastatic Renal Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Pilot Study of Denileukin Diftitox in Combination With High-Dose IL-2 for Patients With Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-05
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 Combinations of biological substances in denileukin diftitox may be able to carry tumor-killing substances directly to kidney cancer cells Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells Giving denileukin diftitox together with interleukin-2 may kill more tumor cells
PURPOSE This randomized phase I trial is studying the side effects of denileukin diftitox and interleukin-2 in treating patients with metastatic kidney cancer
PURPOSE This randomized phase I trial is studying the side effects of denileukin diftitox and interleukin-2 in treating patients with metastatic kidney cancer
Detailed Description:
OBJECTIVES
Primary
Determine the toxic effects of denileukin diftitox and high-dose interleukin-2 in patients with metastatic renal cell cancer
Secondary
Perform transforming growth factor TGF-beta promoter and TGF-beta receptor genotyping to search for variants that may be associated with tumor response to therapy
Determine the overall response rate partial and complete in patients treated with this regimen
Determine the time to progression in patients treated with this regimen
OUTLINE This is a randomized pilot study
The first 3 patients enrolled in the study receive high-dose interleukin-2 IL-2 IV over 15 minutes 3 times daily on days 1-5 and 15-19 and denileukin diftitox IV over 15-60 minutes once daily on days 8-10 If no dose-limiting toxicity occurs after receiving denileukin diftitox subsequent patients are randomized to 1 of 2 treatment arms
Arm I Patients receive denileukin diftitox at a higher dose than for the first 3 patients enrolled in the study IV over 15-60 minutes once daily on days -4 to -2 and high-dose IL-2 IV over 15 minutes 3 times daily on days 1-5 and 15-19
Arm II Patients receive high-dose IL-2 as in arm I and denileukin diftitox at a higher dose than for the first 3 patients enrolled in the study IV over 15-60 minutes at a higher dose once daily on days 8-10
All patients may receive additional treatment with IL-2 alone in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for at least 4 years
PROJECTED ACCRUAL A total of 13 patients will be accrued for this study
Primary
Determine the toxic effects of denileukin diftitox and high-dose interleukin-2 in patients with metastatic renal cell cancer
Secondary
Perform transforming growth factor TGF-beta promoter and TGF-beta receptor genotyping to search for variants that may be associated with tumor response to therapy
Determine the overall response rate partial and complete in patients treated with this regimen
Determine the time to progression in patients treated with this regimen
OUTLINE This is a randomized pilot study
The first 3 patients enrolled in the study receive high-dose interleukin-2 IL-2 IV over 15 minutes 3 times daily on days 1-5 and 15-19 and denileukin diftitox IV over 15-60 minutes once daily on days 8-10 If no dose-limiting toxicity occurs after receiving denileukin diftitox subsequent patients are randomized to 1 of 2 treatment arms
Arm I Patients receive denileukin diftitox at a higher dose than for the first 3 patients enrolled in the study IV over 15-60 minutes once daily on days -4 to -2 and high-dose IL-2 IV over 15 minutes 3 times daily on days 1-5 and 15-19
Arm II Patients receive high-dose IL-2 as in arm I and denileukin diftitox at a higher dose than for the first 3 patients enrolled in the study IV over 15-60 minutes at a higher dose once daily on days 8-10
All patients may receive additional treatment with IL-2 alone in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for at least 4 years
PROJECTED ACCRUAL A total of 13 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 |
|---|---|---|---|
| STU00006770 | OTHER | Northwestern University IRB | httpsreporternihgovquickSearchP30CA060553 |
| P30CA060553 | NIH | None | None |
| NU-04U1 | None | None | None |