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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00055640
First received: March 6, 2003
Last updated: June 9, 2010
Last verified: June 2010
  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:


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:
    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.
    Drug: doxorubicin hydrochloride
    Doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses.
    Drug: prednisone
    Oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses.
    Drug: vincristine sulfate
    Vincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses.
    Genetic: microarray analysis
    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
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
Investigators
Study Chair: Omer N. Koc, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

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
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on July 22, 2014