This phase II trial studies the side effects and how well giving pegfilgrastim together with rituximab works in treating patients with untreated, relapsed, or refractory follicular lymphoma, small lymphocytic lymphoma (SLL), or marginal zone lymphoma (MZL). Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of therapy. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or tumor cancer-killing substances to them. Giving pegfilgrastim together with rituximab may kill more cancer cells
PRIMARY OBJECTIVES: I. To evaluate the safety of Pegfilgrastim in combination with rituximab in patients with untreated or relapsed/refractory follicular, SLL or MZL. SECONDARY OBJECTIVES: I. To evaluate the efficacy (including overall response rate and durability of objective responses) of Pegfilgrastim in combination with rituximab in patients with untreated or relapsed/refractory follicular, SLL or MZL. II. To evaluate functional and phenotypic characteristics of host neutrophils undergoing treatment with Pegfilgrastim and rituximab. III. To evaluate changes in cluster of differentiation (CD)20 antigen expression and density of expression in patients receiving Pegfilgrastim and rituximab. IV. To evaluate changes in serum levels of tumor necrosis factor (TNF), interferon alpha (INFalpha) and free radical levels in patients undergoing treatment with Pegfilgrastim and rituximab. OUTLINE: Patients receive pegfilgrastim subcutaneously (SC) followed by rituximab intravenously (IV) 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 2 years, and then yearly for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Given SC
Given IV
Correlative studies
Correlative studies
Correlative studies
Correlative studies
Roswell Park Cancer Institute
Buffalo, New York, United States
Number of Participants With Adverse Events
Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE
Time frame: Up to 90 days after the last dose of study drugs
Overall Response Rate
Overall Response is defined as Complete Response: During observation, no disease is apparent, including measurable and non-measurable disease, and no evidence of disease is observed for at least 28 days, as confirmed by a second assessment following the original observation of no disease; and Partial Response: A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the 50% or greater decrease, and no appearance of new lesions is noted.
Time frame: Up to 43 weeks
Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline
Mean percent change in CD11b level from baseline at each visit
Time frame: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39
Percent Change in CD20 Antigen Expression and Density of Expression
Percent change in CD20 antigen expression and density of expression
Time frame: At 4 years
Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline
Mean percent change in TNF level from baseline at each visit.
Time frame: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39
Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline
Mean percent change in INF level from baseline.
Time frame: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39
Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline
Mean percent change in MFI level from baseline.
Time frame: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39
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