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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell lymphoma. PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with GM-CSF works in treating patients with newly diagnosed follicular B-cell lymphoma.
OBJECTIVES: Primary * Determine the safety and efficacy of rituximab and sargramostim (GM-CSF), in terms of complete response at 12 weeks, in patients with newly diagnosed follicular B-cell lymphoma. Secondary * Determine the overall response rate in patients treated with this regimen. * Determine the progression-free survival at 3 years in patients treated with this regimen. * Determine the adverse event profile of this regimen in these patients. * Determine the survival of patients treated with this regimen. * Determine the effect of Fc gamma receptor polymorphism on response rate and time to progression in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive rituximab IV on days 1, 8, 15, and 22 and sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5. Treatment with GM-CSF repeats weekly for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection at baseline for correlative laboratory studies of Fc-gamma receptor RIIIa 158 polymorphism. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
375 mg/m\^2 By Vein Weekly on Days 1, 8, 15, and 22.
250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Complete Response Rate
Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities \[e.g., lactate dehydrogenase (LDH)\] definitely assignable to NHL. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.
Time frame: 12 weeks (3 months)
Median Progression-Free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of progression; and, for PFS time calculated from chemo start date to progression date or death date, whichever happened first. Patients were censored at the last follow-up date if neither progression nor death occurred. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. The Kaplan-Meier method was used for time-to-event analysis including PFS.
Time frame: 3 years
Overall Response (OR) Rate
OS defined as percentage of participants alive at a certain period following start of chemotherapy treatment.
Time frame: 3 Months
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