NCT00100906

Sequential ATRA Then IL-2 for Modulation of Dendritic Cells and Treatment of Metastatic Renal Cell Cancer

Randomized Phase II Trial Of Sequential ATRA Then IL-2 For Modulation Of Dendritic Cells And Treatment Of Metastatic Renal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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 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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	IL-2	Immunotherapy with interleukin-2
DRUG	ATRA

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-06-01
• Completion: 2013-07-01
• First posted: 2005-01-07
• Last updated: 2013-08-16

Locations

1 site across 1 country: United States