Lymphoma
Conditions
Keywords
stage I adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALrituximab
Rituximab IV over 3-6 hours.Treatment repeats every 21 days for 3-8 courses.
DRUGcyclophosphamide
Cyclophosphamide IV over 30 minutes. Treatment repeats every 21 days for 3-8 courses.
DRUGdoxorubicin hydrochloride
Doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses.
DRUGprednisone
Oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses.
DRUGvincristine sulfate
Vincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses.
GENETICmicroarray analysis
genetic testing
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma * CD20 and/or CD19 positive by immunohistochemistry or flow cytometry * Disease evaluable by positron-emission tomography scan * Diagnostic tissue (either frozen or fresh unfixed) available for molecular testing or willing to undergo a repeat procedure to obtain such tissue * No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 3 mg/dL Renal * Creatinine no greater than 3 mg/dL Cardiovascular * LVEF at least 40% Other * Not pregnant or nursing * Fertile patients must use effective contraception * No significant organ dysfunction that would preclude study chemotherapy * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy * No prior biological response modifier therapy Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy * No prior radioimmunotherapy Surgery * Not specified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Results from the genetic testing and PET scans at baseline and after course 3 to determine response. |
Countries
United States
Outcome results
None listed