Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100906
Status:
COMPLETED
Last Update Posted:
2013-08-16
First Post:
2005-01-06
Brief Title:
Sequential ATRA Then IL-2 for Modulation of Dendritic Cells and Treatment of Metastatic Renal Cell Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Randomized Phase II Trial Of Sequential ATRA Then IL-2 For Modulation Of Dendritic Cells And Treatment Of Metastatic Renal Cancer
Status:
COMPLETED
Status Verified Date:
2013-07
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 Tretinoin may help cells that are involved in the bodys immune response to work better Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells Giving tretinoin together with interleukin-2 may kill more tumor cells
PURPOSE This randomized phase II trial is studying how well giving three different doses of tretinoin together with interleukin-2 works in treating patients with stage IV kidney cancer
PURPOSE This randomized phase II trial is studying how well giving three different doses of tretinoin together with interleukin-2 works in treating patients with stage IV kidney cancer
Detailed Description:
OBJECTIVES
Primary
Determine the ratio of dendritic cells DC to circulating immature cells ImC before and after treatment with 3 different doses of tretinoin in patients with stage IV renal cell cancer
Assess in vitro immune response assays to tetanus toxoid and influenza virus peptide before and after treatment with tretinoin and interleukin-2 in these patients
Secondary
Determine the frequency of treatment-related side effects in these patients
Determine clinical objective response and progression-free survival of patients treated with this regimen
Correlate DCImC ratio with clinical objective response in patients treated with this regimen
Correlate the extent of change of the DCImC ratio with tretinoin dose and tretinoin blood levels in these patients
OUTLINE This is a randomized open-label study Specimens are stratified according to patient prognostic factors tumor bulk and extent of dendritic cell to circulating immature cell ratio derangement Patients are randomized to 1 of 3 tretinoin doses
Patients are followed for up to 2 years
PROJECTED ACCRUAL A total of 27-36 patients 9-12 per treatment arm will be accrued for this study within 2 years
Primary
Determine the ratio of dendritic cells DC to circulating immature cells ImC before and after treatment with 3 different doses of tretinoin in patients with stage IV renal cell cancer
Assess in vitro immune response assays to tetanus toxoid and influenza virus peptide before and after treatment with tretinoin and interleukin-2 in these patients
Secondary
Determine the frequency of treatment-related side effects in these patients
Determine clinical objective response and progression-free survival of patients treated with this regimen
Correlate DCImC ratio with clinical objective response in patients treated with this regimen
Correlate the extent of change of the DCImC ratio with tretinoin dose and tretinoin blood levels in these patients
OUTLINE This is a randomized open-label study Specimens are stratified according to patient prognostic factors tumor bulk and extent of dendritic cell to circulating immature cell ratio derangement Patients are randomized to 1 of 3 tretinoin doses
Patients are followed for up to 2 years
PROJECTED ACCRUAL A total of 27-36 patients 9-12 per treatment arm will be accrued for this study within 2 years
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 |
|---|---|---|---|
| CA84488 | OTHER_GRANT | NIH | None |
| CA101324 | OTHER_GRANT | None | None |