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Last Modified: 1/7/2009     First Published: 9/24/2003  
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Phase II Study of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone and Radiotherapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Aggressive High-Risk Stage I or IE or Non-Bulky Stage II or IIE CD20-Positive Non-Hodgkin's Lymphoma

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase
 Type
 Status
 Age
 Sponsor
 Protocol IDs

Phase II
Treatment
Active
Over 18
NCI
SWOG-S0313
S0313, NCT00070018

Objectives

  1. 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.
  2. Determine the toxicity of this regimen in these patients.

Entry 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.]

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

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

Expected Enrollment

60

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

Outcomes

Primary Outcome(s)

Progression-free survival at 2 years
Toxicity

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.

Published Results

Miller TP, Unger JM, Spier C, et al.: Effect of adding ibritumomab tiuxetan (Zevalin) radioimmunotherapy consolidation to three cycles of CHOP plus involved-field radiotherapy for limited-stage aggressive diffuse B-cell lymphoma (SWOG 0313). [Abstract] Blood 112 (11): A-3598, 2008.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Thomas Miller, MD, Study coordinator
Ph: 520-626-2667; 800-622-2673
Oliver Press, MD, PhD, Study coordinator
Ph: 206-667-1872
Email: press@u.washington.edu
Baldassarre Stea, MD, PhD, Study coordinator
Ph: 520-694-7238; 800-622-2673
Louis Constine, MD, Study coordinator
Ph: 585-275-5622
Email: louis_constine@urmc.rochester.edu

Trial Sites

U.S.A.
Alaska
  Anchorage
 Alaska Regional Hospital Cancer Center
 Saul Rivkin, MD
Ph: 206-386-2441
 Providence Cancer Center
 Clinical Trials Office - Providence Cancer Center
Ph: 907-261-3109
  Fairbanks
 Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
 Andrew Jacobs, MD
Ph: 206-223-6193
California
  Burbank
 Providence Saint Joseph Medical Center - Burbank
 Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank
Ph: 818-847-3220
Idaho
  Boise
 Mountain States Tumor Institute at St. Luke's Regional Medical Center
 Theodore Walters, MD
Ph: 208-381-2711
Illinois
  Alton
 Saint Anthony's Hospital at Saint Anthony's Health Center
 Bethany Sleckman, MD
Ph: 314-251-7057
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute
Ph: 217-876-6601
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Clinical Trials Office - Cardinal Bernardin Cancer Center
Ph: 708-226-4357
  Mt. Vernon
 Good Samaritan Regional Health Center
 Bethany Sleckman, MD
Ph: 314-251-7057
  Naperville
 Edward Hospital Cancer Center
 Clinical Trials Office - Edward Hospital Cancer Center
Ph: 630-646-6075
  Springfield
 Regional Cancer Center at Memorial Medical Center
 Clinical Trials Office - Regional Cancer Center at Memorial Medical Center
Ph: 217-788-4233
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Liberal
 Southwest Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Topeka
 Cotton-O'Neil Cancer Center
 Clinical Trials Office - Cotton-O'Neil Cancer Center
Ph: 785-270-4963
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wichita
 Associates in Womens Health, PA - North Review
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 CCOP - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Wesley Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
Michigan
  Battle Creek
 Battle Creek Health System Cancer Care Center
 Marianne Lange, MD
Ph: 616-977-6243
  Big Rapids
 Mecosta County Medical Center
 Marianne Lange, MD
Ph: 616-977-6243
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Marianne Lange, MD
Ph: 616-977-6243
 CCOP - Grand Rapids
 Marianne Lange, MD
Ph: 616-977-6243
 Lacks Cancer Center at Saint Mary's Health Care
 Marianne Lange, MD
Ph: 616-977-6243
  Muskegon
 Hackley Hospital
 Marianne Lange, MD
Ph: 616-977-6243
  Southfield
 Providence Cancer Institute at Providence Hospital - Southfield Campus
 Howard Terebelo, DO
Ph: 248-552-0620
  Traverse City
 Munson Medical Center
 Marianne Lange, MD
Ph: 616-977-6243
  Wyoming
 Metro Health Hospital
 Marianne Lange, MD
Ph: 616-977-6243
Missouri
  Cape Girardeau
 Saint Francis Medical Center
 Bethany Sleckman, MD
Ph: 314-251-7057
 Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
 Bethany Sleckman, MD
Ph: 314-251-7057
  Saint Louis
 CCOP - St. Louis-Cape Girardeau
 Bethany Sleckman, MD
Ph: 314-251-7057
 David C. Pratt Cancer Center at St. John's Mercy
 Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy
Ph: 314-251-6770
 Midwest Hematology Oncology Group, Incorporated
 Bethany Sleckman, MD
Ph: 314-251-7057
New York
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Richard Fisher, MD
Ph: 585-275-0842
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Esther Rehmus, MD
Ph: 330-344-6505
  Cincinnati
 Charles M. Barrett Cancer Center at University Hospital
 Leslie Oleksowicz
Ph: 513-584-3200
888-640-CARE
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100
  Independence
 Community Oncology Group at Cleveland Clinic Cancer Center
 George Budd, MD
Ph: 216-444-6480
  Wooster
 Cleveland Clinic - Wooster
 Clinical Trials Office - Cleveland Clinic - Wooster
Ph: 800-862-7798
South Carolina
  Greenville
 CCOP - Greenville
 Jeffrey Giguere, MD, FACP
Ph: 864-987-7000
Washington
  Kirkland
 Cascade Cancer Center at Evergreen Hospital Medical Center
 Andrew Jacobs, MD
Ph: 206-223-6193
  Port Angeles
 Olympic Medical Center
 Andrew Jacobs, MD
Ph: 206-223-6193
  Renton
 Valley Medical Center
 Andrew Jacobs, MD
Ph: 206-223-6193
  Seattle
 CCOP - Virginia Mason Research Center
 Andrew Jacobs, MD
Ph: 206-223-6193
 Group Health Central Hospital
 Clinical Trials Office - Group Health Central Hospital
Ph: 206-287-2900
 Minor and James Medical, PLLC
 Saul Rivkin, MD
Ph: 206-386-2441
 Polyclinic First Hill
 Saul Rivkin, MD
Ph: 206-386-2441
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 Saul Rivkin, MD
Ph: 206-386-2441
 University Cancer Center at University of Washington Medical Center
 Clinical Trials Office - University Cancer Center at University of Washington Medical Center
Ph: 206-616-8289

Registry Information
Official Title 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
Trial Start Date 2004-02-01
Trial Completion Date 2005-04-26 (estimated)
Registered in ClinicalTrials.gov NCT00070018
Date Submitted to PDQ 2003-08-11
Information Last Verified 2009-01-07
NCI Grant/Contract Number CA32102

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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