Clinical Trial: Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

This study is currently recruiting patients.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining chemotherapy with radiation therapy and monoclonal antibody therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining combination chemotherapy with radiation therapy and monoclonal antibody therapy in treating patients who have stage I or stage II non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
adult Burkitt's lymphoma
adult diffuse large cell lymphoma
adult non-Hodgkin's lymphoma
anaplastic large cell lymphoma
Mantle Cell Lymphoma
 Drug: cyclophosphamide
 Drug: doxorubicin
 Drug: prednisone
 Drug: rituximab
 Drug: vincristine
 Drug: yttrium Y 90 ibritumomab tiuxetan
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: isotope therapy
 Procedure: monoclonal antibody therapy
 Procedure: radiation therapy
 Procedure: radioimmunotherapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma;   Viral Infections

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone and Radiotherapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Aggressive Stage I or IE or Non-Bulky Stage II or IIE CD20-Positive Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a multicenter study.

  • Chemotherapy: Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 1-2 hours, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
  • Radiotherapy: Beginning 3 weeks after the completion of CHOP chemotherapy, patients undergo radiotherapy once daily 5 days a week for 4-5 weeks.
  • Monoclonal antibody therapy: Beginning 3-6 weeks after the completion of radiotherapy, patients receive rituximab IV followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients then undergo whole body imaging. If ibritumomab tiuxetan biodistribution is acceptable, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7, 8, OR 9. Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 15 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:
  • Diffuse large B-cell
  • Mantle cell
  • High-grade B-cell, Burkitt's, or Burkitt-like
  • Anaplastic large cell (B-cell phenotype only)
  • Stage I, IE, or non-bulky* stage II or IIE disease by Ann Arbor classification
  • Patients who have bulky stage II or IIE disease are ineligible even if, after resection, the measurements are less than 10.0 cm NOTE: *Non-bulky disease defined as any tumor measuring less than 10.0 cm or occupying less than 1/3 of the chest diameter
  • CD20-expressing disease by flow cytometry or immunoperoxidase staining
  • Aggressive lymphomas must have at least 1 of the following adverse prognostic factors:
  • Non-bulky stage II or IIE disease
  • At least 60 years of age
  • Zubrod performance status of 2
  • Lactic dehydrogenase greater than upper limit of normal
  • All disease must be encompassable in a single radiation port (including any site of resected disease) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age

  • Over 18

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No medical contraindication to study chemotherapy, rituximab, or ibritumomab tiuxetan
  • No known AIDS syndrome or HIV-associated complex

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior radiotherapy for lymphoma
  • No concurrent intensity-modulated radiotherapy
  • Planned involved-field radiotherapy must not encompass more than 25% of active bone marrow space

Surgery

  • See Disease Characteristics

Other

  • Concurrent participation in SWOG-8947 or SWOG-8819 allowed

Location and Contact Information


Alaska
      Providence Alaska Medical Center, Anchorage,  Alaska,  99519-6604,  United States; Recruiting
Contact Person  907-261-4940 

Arizona
      Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson,  Arizona,  85724,  United States; Recruiting
Thomas P. Miller, MD  520-626-2667 

Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Brian F. Issell, MD  808-586-3015    brian@crch.hawaii.edu 

      Tripler Army Medical Center, Honolulu,  Hawaii,  96859-5000,  United States; Recruiting
Brian F. Issell, MD  808-433-4089 

Illinois
      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153-5500,  United States; Recruiting
Patrick J. Stiff, MD  708-327-3148 

      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
James L. Wade, MD  217-876-6617    jlwade3@sbcglobal.net 

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-268-5784 

      Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City,  Kansas,  66160-7353,  United States; Recruiting
Sarah A. Taylor, MD  913-588-6029    sataylor@kumc.edu 

Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States; Recruiting
Glenn M. Mills, MD  318-675-5970    gmills@lsuhsc.edu 

Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
Kathleen Jo Yost, MD  616-391-1230 

      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202,  United States; Recruiting
Robert Anthony Chapman, MD  313-916-1332    rchapma1@hfhs.org 

      Providence Cancer Institute at Providence Hospital - Southfield, Southfield,  Michigan,  48075,  United States; Recruiting
Anibal Drelichman, MD, MPH, FACP  313-552-0620    adrelichman@yahoo.com 

Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
James Tate Thigpen, MD  601-984-5590    jthigpen@medicine.umsmed.edu 

Missouri
      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States; Recruiting
Bethany G. Sleckman, MD  314-569-6573 

New York
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
Richard I. Fisher, MD  585-275-0842    richard_fisher@urmc.rochester.edu 

Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195-9001,  United States; Recruiting
George Thomas Budd, MD  216-444-6480 

South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
Jeffrey Kent Giguere, MD  864-241-6251 

Texas
      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234-6200,  United States; Recruiting
Mitchell A. Garrison, MD  210-916-3281    mitchell.garrison@cen.amedd.army.mil 

Washington
      Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle,  Washington,  98104,  United States; Recruiting
Saul E. Rivkin, MD  206-386-2441    saul.rivkin@swedish.org 

Study chairs or principal investigators

Thomas P. Miller, MD,  Arizona Cancer Center   
Oliver W. Press, MD, PhD,  Fred Hutchinson Cancer Research Center   
Baldassarre Dino Stea, MD, PhD,  Arizona Cancer Center   
Louis S. Constine, MD,  James P. Wilmot Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000329864; SWOG-S0313; NCT00070018
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  October 3, 2003
ClinicalTrials.gov Identifier:  NCT00070018
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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