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

March 6, 2003
June 9, 2010
October 2002
April 2005   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00055640 on ClinicalTrials.gov Archive Site
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Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma
Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
March 2006
April 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00055640
CWRU1402, P30CA043703, CWRU-060244, CWRU-1402
Yes
Omer N. Koc, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Omer N. Koc, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP