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

NCT ID: NCT00055640

Last Updated: 2010-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2006-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

rituximab

Rituximab IV over 3-6 hours.Treatment repeats every 21 days for 3-8 courses.

Intervention Type: BIOLOGICAL

cyclophosphamide

Cyclophosphamide IV over 30 minutes. Treatment repeats every 21 days for 3-8 courses.

Intervention Type: DRUG

doxorubicin hydrochloride

Doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses.

Intervention Type: DRUG

prednisone

Oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses.

Intervention Type: DRUG

vincristine sulfate

Vincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses.

Intervention Type: DRUG

microarray analysis

genetic testing

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Principal Investigators

Omer N. Koc, MD

Role: STUDY_CHAIR

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Locations

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CWRU-060244

Identifier Type: -

Identifier Source: secondary_id

CWRU-1402

Identifier Type: -

Identifier Source: secondary_id

CWRU1402

Identifier Type: -

Identifier Source: org_study_id