Rituximab and Pegfilgrastim in Treating Patients With Non-Hodgkin's Lymphoma
Information source: Roswell Park Cancer Institute
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: pegfilgrastim (Biological); rituximab (Biological); flow cytometry (Other); immunohistochemistry staining method (Other)
Phase: Phase 2
Status: Recruiting
Sponsored by: Roswell Park Cancer Institute Official(s) and/or principal investigator(s):
Francisco J. Hernandez-Ilizaturri, MD, Principal Investigator, Affiliation: Roswell Park Cancer Institute
Summary
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.
Clinical Details
Official title: Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall response rate at weeks 11, 27, and 43
Secondary outcome: Complete response at weeks 11, 27, and 43Partial response at weeks 11, 27, and 43 Time to disease progression Survival
Detailed description:
OBJECTIVES:
Primary
- Evaluate the safety of rituximab and pegfilgrastim in patients with untreated or
relapsed/recurrent follicular lymphoma, small lymphocytic lymphoma, or marginal zone
lymphoma.
Secondary
- 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following indolent, B-cell non-Hodgkin lymphoma:
- Grade 1, 2, or 3a follicular lymphoma
- Small lymphocytic lymphoma
- Marginal zone lymphoma
- Previously untreated, relapsed, or recurrent disease
- No limit to prior treatments
- CD20-positive disease
- Measurable tumor size, defined as at least 1 node measuring 4 cm² bidimensionally
- No premalignant myeloid condition
- No malignancy with myeloid characteristics (e. g., myelodysplastic syndrome, acute or
chronic myelogenous leukemia)
- No CNS lymphoma
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Expected survival > 6 months
- ANC > 1,000/mm³
- Platelet count > 50,000/mm³
- Hemoglobin ≥ 8 g/dL (erythropoietin growth factor allowed)
- Creatinine ≤ 1. 5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1. 5 mg/dL
- AST < 5 times ULN
- Alkaline phosphatase < 5 times ULN
- HIV-negative
- No serious nonmalignant disease (e. g., active uncontrolled bacterial, viral, or
fungal infections) or other conditions that would compromise protocol objectives
- No other malignancy within the past 5 years except squamous cell or basal cell skin
cancer or carcinoma in situ of the cervix
- No history of cardiac disease, defined as NYHA class II-IV cardiac disease
- No clinical evidence of congestive heart failure
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No know hypersensitivity to any recombinant E. coli-derived product, murine proteins,
or any components of the study medication
PRIOR CONCURRENT THERAPY:
- Fully recovered from prior surgery, radiotherapy, chemotherapy, or immunotherapy
- Prior rituximab or other monoclonal immunotherapy allowed
- No chemotherapy within 4 weeks of the first scheduled study treatment
- No major surgery, other than diagnostic surgery, within the past 4 weeks
- More than 30 days since prior participation in another investigational device or drug
trial
- No other concurrent investigational agents
Locations and Contacts
Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States; Recruiting
AskRPCI, Phone: 877-275-7724, Email: AskRPCI@RoswellPark.org
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 2007
Last updated: November 27, 2012
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