Randomized Phase II Trial Of Sequential ATRA Then IL-2 For Modulation Of Dendritic Cells And Treatment Of Metastatic Renal Cancer
- 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
- 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.
- 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
- 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
Ratio of Dendritic Cells (DC) to Circulating Immature Cells (ImC) Before and After Treatment
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.
1 year, 3 months
Mayer Fishman, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|