Rituximab and Dexamethasone in Treating Patients With Low-Grade Non-Hodgkin Lymphoma
This study has been completed.
Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00244855
First received: October 25, 2005
Last updated: August 11, 2011
Last verified: August 2011
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Contiguous Stage II Grade 1 Follicular Lymphoma Contiguous Stage II Grade 2 Follicular Lymphoma Contiguous Stage II Marginal Zone Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Grade 1 Follicular Lymphoma Noncontiguous Stage II Grade 2 Follicular Lymphoma Noncontiguous Stage II Marginal Zone Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Marginal Zone Lymphoma Splenic Marginal Zone Lymphoma Stage I Grade 1 Follicular Lymphoma Stage I Grade 2 Follicular Lymphoma Stage I Marginal Zone Lymphoma Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Marginal Zone Lymphoma Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Marginal Zone Lymphoma Waldenstrom Macroglobulinemia |
Other: pharmacological study Biological: rituximab Drug: dexamethasone Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rituximab and Dexamethasone in CD20 Positive Low Grade and Follicular Non-Hodgkin's Lymphoma |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Rituximab
U.S. FDA Resources
Further study details as provided by Fred Hutchinson Cancer Research Center:
Primary Outcome Measures:
- Clinical RR [ Time Frame: Baseline, and at 3 and 6 months after completion of treatment ] [ Designated as safety issue: No ]Response rates will be assessed separately among previously treated or refractory patients and those previously untreated.
- Rate of Grade II-IV and Grade III-IV infusion-related toxicity [ Time Frame: Weekly during treatment ] [ Designated as safety issue: Yes ]The following symptoms will be specifically sought after and reported as events following each infusion: allergic reaction, arrhythmia, hyper-or hypotension, fever, rigors, chills, urticaria, nausea, vomiting, headache, and infection. Symptoms will be graded based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 55 |
| Study Start Date: | May 2004 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (monoclonal antibody, steroid)
Patients receive dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Biological: rituximab
Given IV
Other Names:
Drug: dexamethasone
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have histologically proven CD20+ low grade B cell lymphoma including follicular, marginal zone, monocytoid B cell, and lymphoplasmacytoid lymphoma; patients may be previously untreated or in relapse
- 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 rituximab therapy within 6 months of entry into protocol
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244855
Locations
| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
| Principal Investigator: | David Maloney | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
No publications provided
| Responsible Party: | Maloney, David, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| ClinicalTrials.gov Identifier: | NCT00244855 History of Changes |
| Other Study ID Numbers: | PSOC 2002, NCI-2011-00576 |
| Study First Received: | October 25, 2005 |
| Last Updated: | August 11, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Waldenstrom Macroglobulinemia Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases |
Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Antibodies Antibodies, Monoclonal Rituximab Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013