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Ibritumomab tiuxetan |
Zevalin |
Clinical Trial: Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma
This study is currently recruiting patients.
Purpose
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: Phase II trial to study the effectiveness of rituximab and combination chemotherapy followed by yttrium Y 90 ibritumomab tiuxetan in treating patients who have previously untreated mantle cell lymphoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma | Drug: cyclophosphamide Drug: doxorubicin Drug: prednisone Drug: rituximab Drug: vincristine Drug: yttrium Y 90 ibritumomab tiuxetan Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: isotope therapy Procedure: monoclonal antibody therapy Procedure: radiation therapy Procedure: radioimmunotherapy | Phase II |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Rituximab and CHOP Chemotherapy Comprising Prednisone, Cyclophosphamide, Doxorubicin, and Vincristine Followed By Yttrium Y 90 Ibritumomab Tiuxetan (Yttrium Y 90 Zevalin®) in Patients With Previously Untreated Mantle Cell Lymphoma
Further Study Details:
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.
- 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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
Alabama
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States; Recruiting
Carla I. Falkson, MD 205-975-2691 cfalkson@uab.edu
Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States; Recruiting
Tom Robert Fitch, MD 480-301-9875
California
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Clinical Trials Office - New Patient Services 800-826-4673 becomingapatient@coh.org
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, 94305-5216, United States; Recruiting
Harlan A. Pinto, MD 650-725-9057
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, 94304-1290, United States; Recruiting
Harlan A. Pinto, MD 650-493-5000 ext. 4948
Colorado
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, 80224, United States; Recruiting
Eduardo R. Pajon, MD 303-777-2663 erpajon@aol.com
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
Stephen Scott Grubbs, MD 302-623-4100
District of Columbia
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting
Lucile L. Adams-Campbell, PhD 202-806-7697
Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, 33612-9497, United States; Recruiting
Cancer Answers 800-456-7121 canceranswers@moffitt.usf.edu
Veterans Affairs Medical Center - Gainesville, Gainesville, Florida, 32608-1197, United States; Recruiting
Dean Latain McCarley, MD 352-374-6016
Veterans Affairs Medical Center - Miami, Miami, Florida, 33125, United States; Recruiting
Niramol Savaraj, MD 305-575-3143 nsavaraj@med.miami.edu
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Julie A. Kish, MD, FACP 813-972-2000
Georgia
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, 30033, United States; Recruiting
Maria Jose Amarante Ribeiro, MD 404-728-7680 maria.ribeiro@med.va.gov
Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322, United States; Recruiting
William Costin Wood, MD 404-778-5180
Illinois
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, MD 217-383-4083 kendrith.rowland@carle.com
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
James L. Wade, MD 217-876-6617 jlwade3@sbcglobal.net
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
Gershon Y. Locker, MD, FACP 847-570-2518 glocker@enh.org
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
John W. Kugler, MD 309-243-3605
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, 60611, United States; Recruiting
Al Bowen Benson, MD, FACP 312-695-1382
Swedish-American Regional Cancer Center, Rockford, Illinois, 61104-2315, United States; Recruiting
Lori Kline, RN, BS 815-489-4413 lkline@swedishamerican.org
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, 60611-4494, United States; Recruiting
Timothy M. Kuzel, MD 312-469-3748
Indiana
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting
Rafat H. Ansari, MD, FACP 574-284-7977
Indiana University Cancer Center, Indianapolis, Indiana, 46202-5289, United States; Recruiting
Patrick J. Loehrer, MD 317-278-7418
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, 46202, United States; Recruiting
Patrick J. Loehrer, MD 317-554-0000
Iowa
Burgess Health Center, Onawa, Iowa, 51040, United States; Recruiting
James A. Mailliard, MD 712-423-2311
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, 52403-1206, United States; Recruiting
Martin Wiesenfeld, MD 319-363-8303
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-244-7586
Des Moines General Hospital, Des Moines, Iowa, 50309, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-247-3121
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, 50316-2301, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-663-5612
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, 50309, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-241-4245
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, 50314, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-247-3121
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-268-5784
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-685-2221
Louisiana
CCOP - Ochsner, New Orleans, Louisiana, 70121, United States; Recruiting
Carl G. Kardinal, MD 504-842-3910
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Jill Gilbert, MD 504-568-5613 jgilbe@lsuhsc.edu
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Michael Benjamin Atkins, MD 617-667-1930
Cancer Center at Tufts - New England Medical Center, Boston, Massachusetts, 02111, United States; Recruiting
John K. Erban, MD 617-636-5147 jerban@tufts-nemc.org
Michigan
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
Raymond Sterling Lord, MD 269-373-7488 rlord@wmcc.org
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237 beekmanl@trinity-health.org
Minnesota
CCOP - Duluth, Duluth, Minnesota, 55805, United States; Recruiting
Robert J. Dalton, MD 218-786-8364 rdalton@smdc.org
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn, MD 952-993-1517 patrick.flynn@usoncology.com
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
Thomas M. Habermann, MD 507-284-2511
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
George L. Adams, MD 612-625-2410 adams002@umn.edu
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, 55417-2399, United States; Recruiting
Markus Gapany, MD, FACS 612-725-2000 ext. 3459 gapan001@maroon.tc.umn.edu
Nebraska
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106, United States; Recruiting
James A. Mailliard, MD 402-280-4364 jamailliard@mrcc.cc
Midlands Cancer Center at Midlands Community Hospital, Papillion, Nebraska, 68128-4157, United States; Recruiting
James A. Mailliard, MD 402-593-3000
Veterans Affairs Medical Center - Omaha, Omaha, Nebraska, 68105, United States; Recruiting
James A. Mailliard, MD 402-280-5274
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
John Allan Ellerton, MD, CM 702-384-0013 k.vanwagenen@sncrf.org
New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
Camilo E. Fadul, MD 603-650-6312 Camilo.e.fadul@dartmouth.edu
New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting
Joseph Aisner, MD 732-235-7401 aisnerjo@umdnj.edu
CCOP - Northern New Jersey, Hackensack, New Jersey, 07601, United States; Recruiting
Richard J. Rosenbluth, MD 201-996-5917
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, 07018, United States; Recruiting
Basil S. Kasimis, MD, DSc 973-676-1000 ext. 7095 Basil.Kasimis@med.va.gov
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Cynthia K. Cathcart, MD 505-272-5688
New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States; Recruiting
Joseph A. Sparano, MD 718-904-2555 jsparano@montefiore.org
MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York, 10466, United States; Recruiting
Peter H. Wiernik, MD 718-920-9900 pwiernik@olmhs.org
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Howard S. Hochster, MD 212-731-5100 howard.hochster@med.nyu.edu
Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York, 11209, United States; Recruiting
Andrea Nadine Wiesel Leaf, MD 718-630-3691
Veterans Affairs Medical Center - New York, New York, New York, 10010, United States; Recruiting
Howard S. Hochster, MD 212-652-1912 howard.hochster@med.nyu.edu
North Dakota
CCOP - Merit Care Hospital, Fargo, North Dakota, 58122, United States; Recruiting
Preston D. Steen, MD 701-234-6298 prestonsteen@meritcare.com
Ohio
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
J. Philip Kuebler, MD, PhD 614-488-2118
CCOP - Toledo Community Hospital, Toledo, Ohio, 43623-3456, United States; Recruiting
Paul L. Schaefer, MD 419-843-6147
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195, United States; Recruiting
Robert Dreicer, MD, FACP 216-445-4623
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Recruiting
Edward G. Mansour, MD 216-778-4394 emansour@metrohealth.org
Oklahoma
CCOP - Oklahoma, Tulsa, Oklahoma, 74136, United States; Recruiting
James B. Lockhart, MD 918-491-5878
Pennsylvania
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Daniel G. Haller, MD 215-662-6318
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
Albert M. Bernath, MD 570-271-6466
CCOP - MainLine Health, Wynnewood, Pennsylvania, 19096, United States; Recruiting
Paul B. Gilman, MD 610-645-2494
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111-2497, United States; Recruiting
Lori J. Goldstein, MD 215-728-2689 lj_goldstein@fccc.edu
Hahnemann University Hospital, Philadelphia, Pennsylvania, 19102-1192, United States; Recruiting
Pamela Ann Crilley, DO 215-762-8547
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15236, United States; Recruiting
John Munn Kirkwood, MD 412-692-4724
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States; Recruiting
Witold Boleslaw Rybka, MD, FRCPC 717-531-1050 wrybka@med.hmc.psu.edu
Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania, 15240, United States; Recruiting
Timothy Carlos, MD 412-688-6248 timothy.carlos@med.va.gov
South Dakota
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57104, United States; Recruiting
Loren K. Tschetter, MD 605-328-8044 tidemanb@siouxvalley.org
Tennessee
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, 37232-6307, United States; Recruiting
David Horton Johnson, MD 615-343-9454 david.h.johnson@vanderbilt.edu
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville, Tennessee, 37212-2637, United States; Recruiting
Kenneth R. Hande, MD 615-327-4751
Texas
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org
Wisconsin
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, 54449, United States; Recruiting
Tarit Kumar Banerjee, MD, FACP 715-387-5511
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, 54301, United States; Recruiting
Gerald K. Bayer, MD 920-433-8889
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, 53226-3596, United States; Recruiting
David H. Vesole, MD, PhD 414-805-4626 dvesole@bmt.mcw.edu
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792-0001, United States; Recruiting
James A. Stewart, MD 608-265-8131 stewart@biostat.wisc.edu
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, 53705, United States; Recruiting
Mark R. Albertini, MD 608-262-7017
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, 53295, United States; Recruiting
Mohammed A. Raheem, MD 414-384-2000
Australia, New South Wales
Westmead Hospital, Westmead, New South Wales, 2145, Australia; Recruiting
Richard Kefford, MD, PhD 61-2-9845-6033
Peru
Instituto de Enfermedades Neoplasicas, Lima, 34, Peru; Recruiting
Carlos Santiago Vallejos-Sologuren, MD 51-14-499-137 postmaster@inen.sld.pe
Puerto Rico
MBCCOP - San Juan, San Juan, 00921-3201, Puerto Rico; Recruiting
Luis Baez-Diaz, MD 787-641-3693 sjccop@prtc.net
San Juan City Hospital, San Juan, 00936-7344, Puerto Rico; Recruiting
Luis Baez-Diaz, MD 787-641-3693 sjccop@prtc.net
Veterans Affairs Medical Center - San Juan, San Juan, 00927-5800, Puerto Rico; Recruiting
Luis Baez-Diaz, MD 787-641-7582 sjccop@prtc.net
South Africa
Pretoria Academic Hospital, Pretoria, 0001, South Africa; Recruiting
Coenraad Frederick Slabber, MD 27-12-354-1054
Study chairs or principal investigators
Mitchell Reed Smith, MD, PhD, Study Chair, Fox Chase Cancer Center
Leo I. Gordon, MD, Robert H. Lurie Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000334470; ECOG-1499; NCT00070447
Record last reviewed: March 2005
Last Updated: March 15, 2005
Record first received: October 3, 2003
ClinicalTrials.gov Identifier: NCT00070447
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: March 2005
Last Updated: March 15, 2005
Record first received: October 3, 2003
ClinicalTrials.gov Identifier: NCT00070447
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Ibritumomab tiuxetan (Drug Digest)
- Zevalin (Drug Digest)
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