Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma
NCT ID: NCT00070447
Last Updated: 2014-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2003-11-30
2006-06-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
yttrium Y 90 ibritumomab tiuxetan
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Principal Investigators
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Mitchell R. Smith, MD, PhD
Role: STUDY_CHAIR
Fox Chase Cancer Center
Leo I. Gordon, MD
Role:
Robert H. Lurie Cancer Center
Locations
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Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Gainesville
Gainesville, Florida, United States
Veterans Affairs Medical Center - Miami
Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Swedish-American Regional Cancer Center
Rockford, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States
Burgess Health Center
Onawa, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Cancer Center at Tufts - New England Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States
Veterans Affairs Medical Center - New York
New York, New York, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
Westmead Hospital
Westmead, New South Wales, Australia
Instituto de Enfermedades Neoplasicas
Lima, , Peru
MBCCOP - San Juan
San Juan, , Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan, , Puerto Rico
San Juan City Hospital
San Juan, , Puerto Rico
Pretoria Academic Hospital
Pretoria, , South Africa
Countries
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References
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Smith MR, Zhang L, Gordon LI, et al.: Phase II study of R-CHOP followed by 90Y-ibritumomab tiuxetan in untreated mantle cell lymphoma: Eastern Cooperative Oncology Group study E1499. [Abstract] Blood 110 (11): A-389, 2007.
Smith MR, Chen H, Gordon L, et al.: Phase II study of rituximab + CHOP followed by 90Y-ibritumomab tiuxetan in patients with previously untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group Study (E1499). [Abstract] J Clin Oncol 24 (Suppl 18): A-7503, 422s, 2006.
Other Identifiers
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ECOG-E1499
Identifier Type: -
Identifier Source: secondary_id
CDR0000334470
Identifier Type: -
Identifier Source: org_study_id
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