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

Purpose

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.

Condition	Intervention	Phase
Lymphoma	Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Genetic: microarray analysis	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma Steroids

Drug Information available for: Cyclophosphamide Prednisone Vincristine sulfate Doxorubicin Doxorubicin hydrochloride Rituximab

Genetic and Rare Diseases Information Center resources: Lymphosarcoma B-cell Lymphoma Lymphoma, Large-cell Diffuse Large B-Cell Lymphoma

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

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. [ Time Frame: Results from the genetic testing and PET scans at baseline and after course 3 to determine response. ] [ Designated as safety issue: No ]


Enrollment:	9
Study Start Date:	October 2002
Study Completion Date:	March 2006
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

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

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

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

genetic testing

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055640

Locations


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

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators


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

More Information


Responsible Party:	Omer N. Koc, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00055640 History of Changes
Other Study ID Numbers:	CWRU1402 P30CA043703 CWRU-060244 CWRU-1402
Study First Received:	March 6, 2003
Last Updated:	June 9, 2010
Health Authority:	United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:


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

Additional relevant MeSH terms:


Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Liposomal doxorubicin Doxorubicin Vincristine Prednisone Immunosuppressive Agents	Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents

ClinicalTrials.gov processed this record on September 30, 2016