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Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00070447
Collaborator
(none)
87
Locations
31
Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: 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. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab and combination chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with previously untreated mantle cell lymphoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the time to treatment failure in patients with previously untreated mantle cell lymphoma treated with rituximab and CHOP chemotherapy comprising prednisone, cyclophosphamide, doxorubicin, and vincristine followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®).

  • Determine the response rate in patients at the completion of rituximab and CHOP and the incremental response rate after IDEC-Y2B8.

  • Determine the toxicity of this regimen in these patients.

  • Correlate serum rituximab levels with response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • CHOP chemotherapy and rituximab: Patients receive cyclophosphamide IV, doxorubicin IV, vincristine IV, and rituximab IV on day 1 and oral prednisone on days 1-5 (R + CHOP). Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients who have responding or stable disease proceed to radioimmunotherapy.

  • Radioimmunotherapy: Within 4-7 weeks after the completion of R + CHOP chemotherapy, patients receive rituximab IV and an imaging dose of indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients then undergo whole body gamma imaging scans during the first day (2-24 hours) and the second or third day (48-72 hours) after injection. In the absence of altered biodistribution, patients receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®) IV over 10 minutes on day 8.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 57 patients will be accrued for this study within 2.8 years.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma
Study Start Date :
Nov 1, 2003
Actual Study Completion Date :
Jun 1, 2006

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 confirmed mantle cell lymphoma with expression of bcl-1 and CD20

    • Stage II-IV disease

    • Measurable or evaluable disease

    • Measurable disease defined as at least 1 bidimensionally measurable lesion at least 2 cm by imaging scan

    • A spleen at least 17 cm or having discrete filling defects by CT scan will constitute evaluable disease provided that no explanation other than lymphomatous involvement (e.g., portal hypertension or other liver disease) is likely

    • No known CNS lymphoma

    PATIENT CHARACTERISTICS:

    Age

    • 18 and over

    Performance status

    • ECOG 0-2

    Life expectancy

    • At least 6 months

    Hematopoietic

    • WBC greater than 2,500/mm^3*

    • Platelet count greater than 100,000/mm^3* NOTE: *Unless due to disease in bone marrow

    Hepatic

    • Bilirubin less than 1.5 mg/dL (1.5-3.0 mg/dL if due to liver involvement by lymphoma)

    • ALT and AST no greater than 2.5 times upper limit of normal (unless due to liver involvement by lymphoma)

    Renal

    • Creatinine less than 2.0 mg/dL

    • Calcium no greater than 11.5 mg/dL

    Cardiovascular

    • LVEF greater than 45%

    Other

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception during and for 1 year after study participation

    • HIV negative

    • No other malignancy except treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer or any other surgically cured malignancy from which the patient has been disease-free for at least 3 years

    • No other concurrent serious medical condition or active infection that would preclude ability to deliver standard prednisone, cyclophosphamide, doxorubicin, and vincristine (CHOP) chemotherapy

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • No prior immunotherapy

    Chemotherapy

    • No prior chemotherapy

    Endocrine therapy

    • Prior corticosteroids allowed provided the course was no more than 2 weeks in duration

    Radiotherapy

    • No prior radiotherapy

    Surgery

    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham Alabama United States 35294-3300
    2 CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale Arizona United States 85259-5404
    3 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    4 Veterans Affairs Medical Center - Palo Alto Palo Alto California United States 94304-1290
    5 Stanford Cancer Center at Stanford University Medical Center Stanford California United States 94305-5216
    6 CCOP - Colorado Cancer Research Program, Incorporated Denver Colorado United States 80224
    7 CCOP - Christiana Care Health Services Newark Delaware United States 19713
    8 MBCCOP - Howard University Cancer Center Washington District of Columbia United States 20060
    9 Veterans Affairs Medical Center - Gainesville Gainesville Florida United States 32608-1197
    10 Veterans Affairs Medical Center - Miami Miami Florida United States 33125
    11 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa Florida United States 33612-9497
    12 Veterans Affairs Medical Center - Tampa (Haley) Tampa Florida United States 33612
    13 Winship Cancer Institute of Emory University Atlanta Georgia United States 30322
    14 Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia United States 30033
    15 Veterans Affairs Medical Center - Lakeside Chicago Chicago Illinois United States 60611-4494
    16 Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago Illinois United States 60611
    17 CCOP - Central Illinois Decatur Illinois United States 62526
    18 CCOP - Evanston Evanston Illinois United States 60201
    19 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615-7828
    20 Swedish-American Regional Cancer Center Rockford Illinois United States 61104-2315
    21 CCOP - Carle Cancer Center Urbana Illinois United States 61801
    22 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    23 Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana United States 46202
    24 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
    25 CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa United States 52403-1206
    26 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309-1016
    27 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
    28 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    29 John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa United States 50316-2301
    30 Burgess Health Center Onawa Iowa United States 51040
    31 CCOP - Wichita Wichita Kansas United States 67214-3882
    32 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
    33 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    34 CCOP - Ochsner New Orleans Louisiana United States 70121
    35 Cancer Center at Tufts - New England Medical Center Boston Massachusetts United States 02111
    36 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    37 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
    38 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
    39 CCOP - Duluth Duluth Minnesota United States 55805
    40 Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota United States 55417-2399
    41 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    42 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    43 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    44 Veterans Affairs Medical Center - Omaha Omaha Nebraska United States 68105
    45 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
    46 Midlands Cancer Center at Midlands Community Hospital Papillion Nebraska United States 68128-4157
    47 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    48 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756-0002
    49 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07018
    50 CCOP - Northern New Jersey Hackensack New Jersey United States 07601
    51 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey United States 08903
    52 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    53 Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx New York United States 10461
    54 MBCCOP-Our Lady of Mercy Cancer Center Bronx New York United States 10466
    55 Veterans Affairs Medical Center - Brooklyn Brooklyn New York United States 11209
    56 Veterans Affairs Medical Center - New York New York New York United States 10010
    57 NYU Cancer Institute at New York University Medical Center New York New York United States 10016
    58 CCOP - Merit Care Hospital Fargo North Dakota United States 58122
    59 MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland Ohio United States 44109
    60 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    61 CCOP - Columbus Columbus Ohio United States 43206
    62 CCOP - Toledo Community Hospital Toledo Ohio United States 43623-3456
    63 CCOP - Oklahoma Tulsa Oklahoma United States 74136
    64 CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania United States 17822-2001
    65 Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    66 Hahnemann University Hospital Philadelphia Pennsylvania United States 19102-1192
    67 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    68 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111-2497
    69 Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania United States 15236
    70 Veterans Affairs Medical Center - Pittsburgh Pittsburgh Pennsylvania United States 15240
    71 CCOP - MainLine Health Wynnewood Pennsylvania United States 19096
    72 CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota United States 57104
    73 Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville Tennessee United States 37212-2637
    74 Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville Tennessee United States 37232-6307
    75 CCOP - Scott and White Hospital Temple Texas United States 76508
    76 CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin United States 54301
    77 Veterans Affairs Medical Center - Madison Madison Wisconsin United States 53705
    78 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-0001
    79 CCOP - Marshfield Clinic Research Foundation Marshfield Wisconsin United States 54449
    80 Medical College of Wisconsin Cancer Center Milwaukee Wisconsin United States 53226-3596
    81 Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin United States 53295
    82 Westmead Hospital Westmead New South Wales Australia 2145
    83 Instituto de Enfermedades Neoplasicas Lima Peru 34
    84 MBCCOP - San Juan San Juan Puerto Rico 00921-3201
    85 Veterans Affairs Medical Center - San Juan San Juan Puerto Rico 00927-5800
    86 San Juan City Hospital San Juan Puerto Rico 00936-7344
    87 Pretoria Academic Hospital Pretoria South Africa 0001

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Mitchell R. Smith, MD, PhD, Fox Chase Cancer Center
    • : Leo I. Gordon, MD, Robert H. Lurie Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00070447
    Other Study ID Numbers:
    • CDR0000334470
    • ECOG-E1499
    First Posted:
    Oct 7, 2003
    Last Update Posted:
    Jan 28, 2014
    Last Verified:
    Oct 1, 2004
    Keywords provided by , ,
    contiguous stage II mantle cell lymphoma
    noncontiguous stage II mantle cell lymphoma
    stage III mantle cell lymphoma
    stage IV mantle cell lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Mantle-Cell
    Prednisone
    Cyclophosphamide
    Rituximab
    Doxorubicin
    Liposomal doxorubicin
    Vincristine

    Study Results

    No Results Posted as of Jan 28, 2014