Rituximab and Pegfilgrastim in Treating Patients With Non-Hodgkin's Lymphoma
RATIONALE: 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. Pegfilgrastim may stimulate the immune system in different ways and stop cancer cells from growing. Giving rituximab together with pegfilgrastim may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with pegfilgrastim works in treating patients with non-Hodgkin's lymphoma.
Other: flow cytometry
Other: immunohistochemistry staining method
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma|
- Overall response rate at weeks 11, 27, and 43 [ Time Frame: AT Weeks 11, 27, 43 ] [ Designated as safety issue: No ]AT Weeks 11, 27, 43
- Complete response at weeks 11, 27, and 43 [ Time Frame: AT Weeks 11, 27, 43 ] [ Designated as safety issue: No ]AT Weeks 11, 27, 43
- Partial response at weeks 11, 27, and 43 [ Time Frame: AT Weeks 11, 27, 43 ] [ Designated as safety issue: No ]AT Weeks 11, 27, 43
- Time to disease progression [ Time Frame: weeks 11,27 and 43 and after 4 months from completion of treatment ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Patients receive pegfilgrastim SC followed by rituximab 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.
Given IVOther: flow cytometry
Correlative StudyOther: immunohistochemistry staining method
- Evaluate the safety of rituximab and pegfilgrastim in patients with untreated or relapsed/recurrent follicular lymphoma, small lymphocytic lymphoma, or marginal zone lymphoma.
- Evaluate the efficacy (including overall response rate and durability of objective responses) of this regimen in these patients.
- Evaluate functional and phenotypic characteristics of host neutrophils.
- Evaluate changes of CD20 antigen expression and density of expression.
- Evaluate changes in serum tumor necrosis factor (TNF), interferon alpha, and free radical levels.
OUTLINE: Patients receive rituximab IV once a week in weeks 1, 3, 5, 7, 15, 23, 31, and 39 and pegfilgrastim subcutaneously 3 days before receiving rituximab for a total of 8 doses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study treatment for correlative studies. Samples are analyzed for phenotype changes in neutrophils, oxidative burst, and cytokine levels by flow cytometry and in vitro functional assays. Patients with easily accessible lymphomatous lesions undergo excisional biopsy within 24 hours after completion of first dose of rituximab. Tissues are analyzed for infiltration of neutrophils into tumor bed, changes in CD20 expression by immunohistochemistry, flow cytometry, and western blot, and evidence of apoptosis.
After completion of study treatment, patients are followed every 4 months for 1 year, every 6 months for 2 years, and once at year 4.
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263-0001|
|Contact: AskRPCI 877-275-7724 AskRPCI@RoswellPark.org|
|Principal Investigator:||Francisco J. Hernandez-Ilizaturri, MD||Roswell Park Cancer Institute|