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

June 9, 2010 updated by: Case Comprehensive Cancer Center

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

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 Overview

Status

Completed

Conditions

Lymphoma

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Ohio
  - Cleveland, Ohio, United States, 44106-7284
    - Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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. Time Frame: Results from the genetic testing and PET scans at baseline and after course 3 to determine response.	Results from the genetic testing and PET scans at baseline and after course 3 to determine response.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

March 6, 2003

First Submitted That Met QC Criteria