RATIONALE: Analyzing genes that are present in cancer cells may be useful as a method for predicting the response of non-Hodgkin's lymphoma to cancer treatment. Imaging procedures such as positron emission tomography (PET) scans may improve the ability to measure how well cancer has responded to treatment. PURPOSE: This phase II trial is studying molecular risk assessment to see how well it works in predicting response to therapy in patients who are receiving treatment for non-Hodgkin's lymphoma.
OBJECTIVES: * Determine whether molecular risk assessment can identify groups of patients with diffuse large B-cell non-Hodgkin's lymphoma (NHL) who will demonstrate at least 50% difference in early response rates to treatment as determined by positron-emission tomography (PET) imaging. * Determine, by PET imaging, the response rate of patients treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab. * Determine whether early response rates can be predicted by gene expression profiles at diagnosis in these patients. * Compare gene expression profiles of patients with refractory or relapsed large cell NHL with profiles of the disease at diagnosis. * Determine relapse-free and overall survival rates of these patients. * Determine the feasibility of a new NHL treatment algorithm based on prognostic index and molecular risk, and early response assessment by PET imaging. OUTLINE: Molecular risk assessment is performed using lymph node tissue from initial diagnosis to test for "activated" genes before starting treatment. Patients receive rituximab IV over 3-6 hours, cyclophosphamide IV over 30 minutes, doxorubicin IV over 5 minutes, and vincristine IV over 5 minutes on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses. Patients undergo whole-body positron-emission tomography (PET) scanning at baseline and after course 3 to determine response. Results from the genetic testing and PET scans are used to determine further treatment recommendations. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 36-50 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Rituximab IV over 3-6 hours.Treatment repeats every 21 days for 3-8 courses.
Cyclophosphamide IV over 30 minutes. Treatment repeats every 21 days for 3-8 courses.
Doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses.
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Molecular risk assessment to see how well it works in predicting response to therapy in patients who are receiving treatment for non-Hodgkin's lymphoma.
Time frame: Results from the genetic testing and PET scans at baseline and after course 3 to determine response.
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Masking
NONE
Enrollment
9
Oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses.
Vincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses.
genetic testing