Clinical Trials Directory

Trials / Completed

CompletedNCT00010192

Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer

A Phase I Trial Of Rituximab And Interleukin-2

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
30 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells. Phase I trial to study the effectiveness of rituximab plus interleukin-2 in treating patients who have hematologic cancer.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALrituximabGiven IV
BIOLOGICALaldesleukinGiven SC
OTHERlaboratory biomarker analysisCorrelative studies
OTHERpharmacological studyCorrelative studies

Timeline

Start date
2000-12-01
Primary completion
2003-01-01
First posted
2003-01-27
Last updated
2013-06-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00010192. Inclusion in this directory is not an endorsement.