Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma

Lymphoma Clinical Trial

Official title: Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

• NCT number: NCT00055640
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: October 2002
• Completion date: March 2006