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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
microarray analysis
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2003
Last Updated
June 9, 2010
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00055640
Brief Title
Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma
Official Title
Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I adult diffuse large cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Description
Rituximab IV over 3-6 hours.Treatment repeats every 21 days for 3-8 courses.
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
Cyclophosphamide IV over 30 minutes. Treatment repeats every 21 days for 3-8 courses.
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Description
Doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses.
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
Oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses.
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Description
Vincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses.
Intervention Type
Genetic
Intervention Name(s)
microarray analysis
Intervention Description
genetic testing
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer N. Koc, MD
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-7284
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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