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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 ongoing, but not recruiting participants.
Study NCT00070018   Information provided by National Cancer Institute (NCI)
First Received: October 3, 2003   Last Updated: April 14, 2009   History of Changes

October 3, 2003
April 14, 2009
February 2004
December 2008   (final data collection date for primary outcome measure)
  • Progression-free survival at 2 years [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Progression-free survival at 2 years
  • Toxicity
Complete list of historical versions of study NCT00070018 on ClinicalTrials.gov Archive Site
 
 
 
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
Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin Lymphoma, Phase II

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: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy and monoclonal antibody therapy works in treating patients with stage I or stage II non-Hodgkin's lymphoma.

OBJECTIVES:

  • Determine the 2-year progression-free survival of patients with aggressive high-risk stage I or IE or non-bulky stage II or IIE CD20-positive non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone and radiotherapy followed by rituximab and yttrium Y 90 ibritumomab tiuxetan.
  • Determine the toxicity of this regimen in these patients.

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.

Phase II
Interventional
Treatment, Open Label
Lymphoma
  • Biological: rituximab
  • Drug: CHOP regimen
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: prednisone
  • Drug: vincristine sulfate
  • Radiation: radiation therapy
  • Radiation: yttrium Y 90 ibritumomab tiuxetan
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
60
 
December 2008   (final data collection date for primary outcome measure)

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

  • No prior monoclonal antibody therapy

Chemotherapy

  • No prior chemotherapy for lymphoma

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00070018
Laurence H. Baker, Southwest Oncology Group - Group Chair's Office
CDR0000329864, SWOG-S0313
Southwest Oncology Group
National Cancer Institute (NCI)
Investigator: Thomas P. Miller, MD University of Arizona
Investigator: Oliver W. Press, MD, PhD Fred Hutchinson Cancer Research Center
Investigator: Baldassarre D. Stea, MD, PhD University of Arizona
Investigator: Louis S. Constine, MD James P. Wilmot Cancer Center
National Cancer Institute (NCI)
January 2009

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