Expired Study
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Cleveland, Ohio 44106


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00055640


Primary Contact:

Study Chair
Omer N. Koc, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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