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S0019 Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Sponsor
Southwest Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT00006708
Collaborator
National Cancer Institute (NCI) (NIH)
7
Enrollment
85
Locations
2
Arms
73
Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab for non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without rituximab in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Oct 1, 2000
Actual Primary Completion Date :
Nov 1, 2002
Actual Study Completion Date :
Nov 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: ICE Chemotherapy

Etoposide 100 mg/m2 IV Days 1-3 Carboplatin AUC=5 IV Day 2 Ifosfamide 5 g/m2 IV Day 2 Mesna 5 g/m2 IV Day 2 Filgrastim 5ug/kg/day SQ Days 5-12 Q 21 days x 3 cycles

Biological: filgrastim
5 μg/kg/day subcutaneous injection on Days 5-12 every 21 days for 3 cycles.

Drug: carboplatin

Drug: etoposide

Drug: ifosfamide
Experimental: Rituximab-ICE Chemotherapy

Etoposide 100 mg/m2 IV Days 2-4 Carboplatin AUC=5 IV Day 3 Ifosfamide 5 g/m2 IV Day 3 Mesna 5 g/m2 IV Day 3 Filgrastim 5ug/kg/day SQ Days 6-13 Q 21 days x 3 cycles Rituximab 375 mg/m2 IV Days 1 and 8 Cycle 1 Rituximab 375 mg/m2 IV Day 1 Cycles 2-3

Biological: filgrastim
5 μg/kg/day subcutaneous injection on Days 5-12 every 21 days for 3 cycles.

Biological: rituximab

Drug: carboplatin

Drug: etoposide

Drug: ifosfamide

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MBCCOP - Gulf Coast Mobile Alabama United States 36688
    2 CCOP - Greater Phoenix Phoenix Arizona United States 85006-2726
    3 Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix Arizona United States 85012
    4 Veterans Affairs Medical Center - Tucson Tucson Arizona United States 85723
    5 Arizona Cancer Center Tucson Arizona United States 85724
    6 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    7 Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas United States 72205
    8 Cancer Center and Beckman Research Institute, City of Hope Duarte California United States 91010-3000
    9 Veterans Affairs Medical Center - Long Beach Long Beach California United States 90822
    10 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
    11 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    12 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
    13 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    14 Chao Family Comprehensive Cancer Center Orange California United States 92868
    15 University of California Davis Medical Center Sacramento California United States 95817
    16 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    17 David Grant Medical Center Travis Air Force Base California United States 94535
    18 University of Colorado Cancer Center Denver Colorado United States 80010
    19 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
    20 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
    21 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
    22 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
    23 CCOP - Central Illinois Decatur Illinois United States 62526
    24 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
    25 Loyola University Medical Center Maywood Illinois United States 60153
    26 University of Kansas Medical Center Kansas City Kansas United States 66160-7357
    27 CCOP - Wichita Wichita Kansas United States 67214-3882
    28 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
    29 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40511-1093
    30 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    31 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    32 Tulane University School of Medicine New Orleans Louisiana United States 70112
    33 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
    34 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71130
    35 Boston Medical Center Boston Massachusetts United States 02118
    36 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
    37 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
    38 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
    39 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    40 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
    41 Henry Ford Hospital Detroit Michigan United States 48202
    42 CCOP - Grand Rapids Clinical Oncology Program Grand Rapids Michigan United States 49503
    43 Providence Hospital - Southfield Southfield Michigan United States 48075-9975
    44 Veterans Affairs Medical Center - Biloxi Biloxi Mississippi United States 39531-2410
    45 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    46 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
    47 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
    48 Veterans Affairs Medical Center - Kansas City Kansas City Missouri United States 64128
    49 CCOP - Kansas City Kansas City Missouri United States 64131
    50 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110-0250
    51 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
    52 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    53 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    54 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
    55 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    56 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    57 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45219
    58 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
    59 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    60 CCOP - Columbus Columbus Ohio United States 43206
    61 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
    62 CCOP - Dayton Kettering Ohio United States 45429
    63 Oklahoma Medical Research Foundation Oklahoma City Oklahoma United States 73104
    64 Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma United States 73104
    65 Oregon Cancer Center Portland Oregon United States 97201-3098
    66 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
    67 CCOP - Columbia River Program Portland Oregon United States 97213
    68 CCOP - Greenville Greenville South Carolina United States 29615
    69 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    70 Veterans Affairs Medical Center - Dallas Dallas Texas United States 75216
    71 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    72 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    73 University of Texas Medical Branch Galveston Texas United States 77555-0209
    74 Texas Tech University Health Science Center Lubbock Texas United States 79423
    75 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7811
    76 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78284
    77 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
    78 CCOP - Scott and White Hospital Temple Texas United States 76508
    79 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    80 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
    81 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
    82 Swedish Cancer Institute Seattle Washington United States 98104
    83 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
    84 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1024
    85 CCOP - Northwest Tacoma Washington United States 98405-0986

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: David G. Maloney, MD, PhD, Fred Hutchinson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00006708
    Other Study ID Numbers:
    • CDR0000068320
    • S0019
    • U10CA032102
    First Posted:
    Mar 17, 2004
    Last Update Posted:
    Apr 10, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Southwest Oncology Group
    recurrent adult diffuse large cell lymphoma
    recurrent adult Burkitt lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Rituximab
    Carboplatin
    Etoposide
    Ifosfamide

    Study Results

    No Results Posted as of Apr 10, 2013