A Phase I Trial Of Rituximab And Interleukin-2
OBJECTIVES: Determine the dose-limiting toxicity of rituximab followed by low-dose and
intermediate-dose pulse interleukin-2 (IL-2) in patients with CD20-positive B-cell lymphoid
Determine the maximum tolerated dose of intermediate-dose pulse IL-2 in this patient
Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study of intermediate-dose pulse aldesleukin.
Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose
aldesleukin subcutaneously (SC) on days 29-39, 43-53, 57-67, and 71-81, and
intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84. Cohorts of 3-6
patients receive escalating doses of intermediate-dose pulse aldesleukin until the maximum
tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at
least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 1 year.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose preceding that at which at least 2 of 6 patients experience DLT using NCI CTC version 2.0
Data collected will be descriptive and provide limited estimates of variability given the small sample sizes at each dose level.
Ohio State University
United States: Food and Drug Administration
|Ohio State University Medical Center||Columbus, Ohio 43210|