Kidney Cancer Clinical Trial
Official title:
Randomized Phase II Trial Of Sequential ATRA Then IL-2 For Modulation Of Dendritic Cells And Treatment Of Metastatic Renal Cancer
RATIONALE: Tretinoin may help cells that are involved in the body's 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.
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 DC:ImC ratio with clinical objective response in patients treated with this
regimen.
- Correlate the extent of change of the DC:ImC 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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