Clinical Trials Directory

Trials / Completed

CompletedNCT00244855

Rituximab and Dexamethasone in Treating Patients With Low-Grade Non-Hodgkin Lymphoma

Rituximab and Dexamethasone in CD20 Positive Low Grade and Follicular Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies the side effects and how well giving rituximab and dexamethasone together works in treating patients with low-grade non-Hodgkin lymphoma (NHL). Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with dexamethasone may kill more cancer cells

Detailed description

PRIMARY OBJECTIVES: I. To estimate clinical response rate (RR) at 3 and 6 months. II. To estimate Grade 2-4 -infusion-related toxicity. SECONDARY OBJECTIVES: I. To evaluate laboratory parameters and correlate with clinical response including: antibody dependent cell mediated cytotoxicity and effector cell phenotype analysis at baseline, 4 weeks and three months. II. To evaluate laboratory parameters and correlate with clinical response including: soluble cluster of differentiation (CD)20 fragments or CD20-containing membrane fragments at baseline, 4 weeks, and 3 months. III. To evaluate laboratory parameters and correlate with clinical response including: phenotype analysis of CD16 and CD32 on natural killer (NK) cells. IV. To evaluate laboratory parameters and correlate with clinical response including: rituximab pharmacokinetic studies at baseline, 4 weeks and 3 months. OUTLINE: Patients receive dexamethasone intravenously (IV) and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3 and 6 months.

Conditions

Interventions

TypeNameDescription
OTHERpharmacological studyCorrelative studies
BIOLOGICALrituximabGiven IV
DRUGdexamethasoneGiven IV
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2004-05-01
Primary completion
2008-12-01
Completion
2011-08-29
First posted
2005-10-27
Last updated
2017-05-22
Results posted
2017-05-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00244855. Inclusion in this directory is not an endorsement.