Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma
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 ZevalinĀ®).
- 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 ZevalinĀ®) 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Mitchell R. Smith, MD, PhD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000334470
NCT00070447
November 2003
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Evanston | Evanston, Illinois 60201 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Cancer Center at Tufts - New England Medical Center | Boston, Massachusetts 02111 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - New York | New York, New York 10010 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
Veterans Affairs Medical Center - Pittsburgh | Pittsburgh, Pennsylvania 15240 |
Veterans Affairs Medical Center - Miami | Miami, Florida 33125 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Midlands Cancer Center at Midlands Community Hospital | Papillion, Nebraska 68128-4157 |
CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
Stanford Cancer Center at Stanford University Medical Center | Stanford, California 94305 |
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | Nashville, Tennessee 37212 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
MBCCOP-Our Lady of Mercy Cancer Center | Bronx, New York 10466 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - Gainesville | Gainesville, Florida 32608-1197 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Burgess Health Center | Onawa, Iowa 51040 |
Veterans Affairs Medical Center - Omaha | Omaha, Nebraska 68105 |
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |