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A Randomized Phase III Trial of ICE Chemotherapy With or Without Rituximab for the Treatment of Relapsed or Refractory CD20 Expressing Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients Not Suitable for High Dose Therapy and PBSCT


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Randomized Phase III Trial of ICE Chemotherapy With or Without Rituximab for the Treatment of Relapsed or Refractory CD20 Expressing Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients Not Suitable for High Dose Therapy and PBSCT


OBJECTIVES: I. Compare the progression-free and overall survival of patients with relapsed
or refractory, CD20 expressing, aggressive, B-cell non-Hodgkin's lymphoma treated with
ifosfamide, carboplatin, and etoposide with or without rituximab. II. Compare the
unconfirmed response rate of patients treated with these regimens. III. Determine the
toxicity of ifosfamide, carboplatin, and etoposide with rituximab in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to histology (large
B-cell vs other) and risk group (low/low-intermediate vs high-intermediate/high). Patients
are randomized to one of two treatment arms. Arm I: Patients receive etoposide IV over 1
hour on days 1-3, carboplatin IV over 1 hour on day 2, ifosfamide IV continuously for 24
hours on day 2, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment continues
every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive rituximab IV on day 1, etoposide IV over 1 hour on days 2-4,
carboplatin IV over 1 hour on day 3, ifosfamide IV continuously for 24 hours on day 3, and
G-CSF SC on days 6-13. Patients also receive rituximab IV on day 8 of course 1. Treatment
continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable
toxicity. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and
then annually for 5 years.

PROJECTED ACCRUAL: A total of 376 patients (188 per arm) will be accrued for this study
within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven aggressive B-cell non-Hodgkin's lymphoma
that has failed prior combination chemotherapy with an anthracycline-containing regimen
Eligible histologies: Diffuse large cell Small non-cleaved cell/Burkitt's lymphoma No
lymphoblastic or mantle cell lymphoma First relapse or primary refractory disease
Ineligible for or refused treatment with salvage chemotherapy followed by high-dose
therapy and autologous stem cell rescue Documented CD20 antigen expression Measurable
disease No clinical evidence of CNS involvement by lymphoma

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper
limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance
greater than 60 mL/min Other: HIV negative Not pregnant or nursing 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

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior rituximab
Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy:
Not specified Surgery: Not specified Other: Recovered from toxic effects of all prior
therapy No other concurrent therapy unless disease progression occurs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

David G. Maloney, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

CDR0000068320

NCT ID:

NCT00006708

Start Date:

October 2000

Completion Date:

November 2006

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult Burkitt lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Arizona Cancer Center Tucson, Arizona  85724
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
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
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
Loyola University Medical Center Maywood, Illinois  60153
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 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
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
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
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
Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix, Arizona  85012
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center Portland, Oregon  97201-3098
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216