Rituximab and Dexamethasone in Treating Patients With Low-Grade Non-Hodgkin Lymphoma
NCT ID: NCT00244855
Last Updated: 2017-05-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2004-05-31
2011-08-29
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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No previous treatment
Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study
Correlative studies
rituximab
Given IV
dexamethasone
Given IV
laboratory biomarker analysis
Correlative studies
Previous treatment
Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
pharmacological study
Correlative studies
rituximab
Given IV
dexamethasone
Given IV
laboratory biomarker analysis
Correlative studies
Interventions
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pharmacological study
Correlative studies
rituximab
Given IV
dexamethasone
Given IV
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have measurable disease with clearly defined margins assessed by physical exam with direct measurement (for cutaneous B-cell lymphomas), computed tomography (CT) or magnetic resonance imaging (MRI), defined as \>= 20 mm with conventional CT or MRI or \>= 10 mm using spiral CT scan
* Absolute neutrophil count \>= 1000/mm\^3
* Hemoglobin \> 7 g/dl
* Platelets \>= 100,000/mm\^3
* Serum creatinine =\< 2.5 mg/dl
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2x the upper limit of normal (ULN)
* Karnofsky performance score \>= 70 %
* Patient has signed an Institutional Review Board (IRB) approved informed consent form that conforms to federal and institutional guidelines
Exclusion Criteria
* Patient has received systemic steroid therapy within one month of entry into protocol
* Patient has Intermediate or High Grade NHL, mantle cell lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
* Patient is pregnant or lactating
* Patient is unwilling or unable to practice contraception during treatment and for one year thereafter
* Patient has active central nervous system (CNS) disease
* Patient has human immunodeficiency virus (HIV) disease
* Patient has an active infection requiring antimicrobial therapy
* Patient has significant heart disease, New York Heart Classification III or IV heart disease (III: Marked limitation of physical activity; comfortable at rest, but less than ordinary activity causes fatigue, or dyspnea; IV: Unable to carry on any physical activity without symptoms; symptoms are present even at rest; if any physical activity is undertaken, symptoms are increased)
* Patient requires supplemental oxygen
* Patient has a concomitant malignancy or previous malignancy within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, or in situ cervical or in situ breast cancer
* Patients with active hepatitis B virus (HBV) infection or hepatitis, or with hepatitis C positive serology
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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David Maloney
Principal Investigator
Principal Investigators
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David Maloney
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2011-00576
Identifier Type: REGISTRY
Identifier Source: secondary_id
PSOC 2002
Identifier Type: -
Identifier Source: org_study_id
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