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Evaluation of CHOP Plus Rituximab Plus Involved Field Radiotherapy for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized Aggressive Histologies of Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

Evaluation of CHOP Plus Rituximab Plus Involved Field Radiotherapy for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized Aggressive Histologies of Non-Hodgkin's Lymphoma


OBJECTIVES: I. Assess two year progression free survival after treatment with
cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus rituximab followed by
radiotherapy in patients with stage I, IE, or non-bulky stage II or IIE high risk localized
intermediate or high grade non-Hodgkin's lymphoma. II. Determine the toxicity of this
treatment in these patients.

OUTLINE: Patients receive rituximab IV on days 1 and 8 of the first course, then on day 1 of
courses 2 and 3. Patients receive cyclophosphamide IV over 1-2 hours, doxorubicin IV, and
vincristine IV on day 10 of the first course, then on day 3 of courses 2 and 3. Patients
receive oral prednisone on days 10-14 of the first course, then on days 3-7 of courses 2 and
3. Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity. Chemotherapy is followed by radiotherapy administered 5 days a week
for 4-5 weeks. Patients are followed every 6 months for two years, and then annually
thereafter.

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

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage I, IE, or non-bulky II or IIE
non-Hodgkin's lymphoma of one 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)
Lymphoma must express CD20 All disease must be encompassable in a single radiation port
(including any resected disease) Must have at least 1 of the following adverse prognostic
features: Non-bulky stage II or non-bulky stage IIE disease Over 60 years of age Zubrod
performance status of 2 Elevated serum LDH 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:
No medical contraindications to CHOP chemotherapy or rituximab No prior malignancy within
past 5 years except adequately treated basal cell or squamous cell skin cancer or
carcinoma in situ of the cervix No AIDS or HIV Not pregnant or nursing Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy
Chemotherapy: No prior chemotherapy for lymphoma Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy for lymphoma Surgery: Not specified

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

every 6 weeks while on protocol treatment, then every 6 months for 2 years, then annually thereafter

Safety Issue:

No

Principal Investigator

Thomas P. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Federal Government

Study ID:

CDR0000067707

NCT ID:

NCT00005089

Start Date:

April 2000

Completion Date:

January 2017

Related Keywords:

  • Lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult Burkitt lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Arizona Cancer Center Tucson, Arizona  85724
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of California Davis Medical Center Sacramento, California  95817
CCOP - Wichita Wichita, Kansas  67214-3882
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
CCOP - Duluth Duluth, Minnesota  55805
Loyola University Medical Center Maywood, Illinois  60153
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - Gulf Coast Mobile, Alabama  36688
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
Veterans Affairs Medical Center - West Los Angeles Los Angeles, California  90073
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Texas Tech University Health Science Center Lubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Madigan Army Medical Center Tacoma, Washington  98431-5048
Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center Portland, Oregon  97201-3098
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216