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
malignancy.
Determine the maximum tolerated dose of intermediate-dose pulse IL-2 in this patient
population.
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.
Interventional
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.
2 weeks
Yes
Pierluigi Porcu
Principal Investigator
Ohio State University
United States: Food and Drug Administration
NCI-2012-01404
NCT00010192
December 2000
Name | Location |
|---|---|
| Ohio State University Medical Center | Columbus, Ohio 43210 |
