Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00055640|
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : June 10, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Genetic: microarray analysis||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma|
|Study Start Date :||October 2002|
|Primary Completion Date :||April 2005|
|Study Completion Date :||March 2006|
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055640
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-7284|
|Study Chair:||Omer N. Koc, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|