NCT00055640

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	Rituximab IV over 3-6 hours.Treatment repeats every 21 days for 3-8 courses.
DRUG	cyclophosphamide	Cyclophosphamide IV over 30 minutes. Treatment repeats every 21 days for 3-8 courses.
DRUG	doxorubicin hydrochloride	Doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses.
DRUG	prednisone	Oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses.
DRUG	vincristine sulfate	Vincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses.
GENETIC	microarray analysis	genetic testing

Timeline

• Start date: 2002-10-01
• Primary completion: 2005-04-01
• Completion: 2006-03-01
• First posted: 2003-03-07
• Last updated: 2010-06-10

Locations

1 site across 1 country: United States