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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055640
• Other study ID #: CWRU1402
• Secondary ID: P30CA043703CWRU-
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2003
• Last updated: June 9, 2010
• Start date: October 2002
• Est. completion date: March 2006

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2006
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

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.
• doxorubicin hydrochloride
Doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses.
• prednisone
Oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses.
• vincristine sulfate
Vincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses.

Genetic:
• microarray analysis
genetic testing

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Results from the genetic testing and PET scans at baseline and after course 3 to determine response.	No