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Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma Clinical research trials and Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma. Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.

Home > "R" Clinical Trials Conditions > Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma

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



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

For Condition: contiguous stage 2 mantle cell lymphoma,noncontiguous stage 2 mantle cell lymphoma,stage 3 mantle cell lymphoma,stage 4 mantle cell lymphoma
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 - 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
LeoGordon,  ,  Robert H. Lurie Cancer Center

John Stoddard Cancer Center at Iowa Methodist Medical Center *Recruiting*
Des Moines,  Iowa,  50309
United States
Recruiting Roscoe  Morton 515-241-4245

Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh,  Pennsylvania,  15236
United States
Recruiting John  Kirkwood 412-692-4724

University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison,  Wisconsin,  53792-0001
United States
Recruiting James  Stewart 608-265-8131

CCOP - MainLine Health *Recruiting*
Wynnewood,  Pennsylvania,  19096
United States
Recruiting Paul  Gilman 610-645-2057

MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Jill  Gilbert 504-568-5136

CCOP - Central Illinois *Recruiting*
Decatur,  Illinois,  62526
United States
Recruiting James  Wade 217-876-6617

Veterans Affairs Medical Center - Miami *Recruiting*
Miami,  Florida,  33125
United States
Recruiting Niramol  Savaraj 305-324-3143

Des Moines General Hospital *Recruiting*
Des Moines,  Iowa,  50309
United States
Recruiting Roscoe  Morton 515-247-3121

Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford,  California,  94305-5216
United States
Recruiting Harlan  Pinto 650-725-9057

Beth Israel Deaconess Medical Center *Recruiting*
Boston,  Massachusetts,  02215
United States
Recruiting Michael  Atkins 617-667-1930

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Philip  Stella 734-712-2000

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Tarit  Banerjee 715-387-5134

Veterans Affairs Medical Center - Milwaukee (Zablocki) *Recruiting*
Milwaukee,  Wisconsin,  53295
United States
Recruiting Mohammed  Raheem 414-384-2000

Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia,  Pennsylvania,  19104
United States
Recruiting Daniel  Haller 215-662-6318

CCOP - Oklahoma *Recruiting*
Tulsa,  Oklahoma,  74136
United States
Recruiting James  Lockhart 918-491-5878

CCOP - Ochsner *Recruiting*
New Orleans,  Louisiana,  70121
United States
Recruiting Carl  Kardinal 504-842-3910

Iowa Lutheran Hospital *Recruiting*
Des Moines,  Iowa,  50316-2301
United States
Recruiting Roscoe  Morton 515-663-5612

CCOP - Wichita *Recruiting*
Wichita,  Kansas,  67214-3882
United States
Recruiting Shaker  Dakhil 316-268-5784

Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland,  Ohio,  44195
United States
Recruiting Robert  Dreicer 216-445-4623

CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas,  Nevada,  89106
United States
Recruiting John  Ellerton 702-384-0013

Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey,  Pennsylvania,  17033-0850
United States
Recruiting Witold  Rybka 717-531-1050

CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale,  Arizona,  85259-5404
United States
Recruiting Tom  Fitch 480-301-9875

Burgess Health Center *Recruiting*
Onawa,  Iowa,  51040
United States
Recruiting James  Mailliard 712-423-2311

Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita,  Kansas,  67218
United States
Recruiting Shaker  Dakhil 316-685-2221

Fox Chase Cancer Center *Recruiting*
Philadelphia,  Pennsylvania,  19111-2497
United States
Recruiting Lori  Goldstein 215-728-2689

City of Hope Comprehensive Cancer Center *Recruiting*
Duarte,  California,  91010-3000
United States
Recruiting Theodore  Krontiris 626-301-8164

CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha,  Nebraska,  68106
United States
Recruiting James  Mailliard 402-280-4364

Cancer Institute of New Jersey *Recruiting*
New Brunswick,  New Jersey,  08903
United States
Recruiting Joseph  Aisner 732-235-7464

MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C.,  District of Columbia,  20060
United States
Recruiting Lucile  Adams-Campbell 202-806-7697

Veterans Affairs Medical Center - Pittsburgh *Recruiting*
Pittsburgh,  Pennsylvania,  15240
United States
Recruiting Timothy  Carlos 412-688-6248

Midlands Cancer Center at Midlands Community Hospital *Recruiting*
Papillion,  Nebraska,  68128-4157
United States
Recruiting James  Mailliard 402-593-3000

CCOP - Northern New Jersey *Recruiting*
Hackensack,  New Jersey,  07601
United States
Recruiting Richard  Rosenbluth 201-996-5917

Veterans Affairs Medical Center - Atlanta (Decatur) *Recruiting*
Decatur,  Georgia,  30033
United States
Recruiting Maria  Amarante Ribeiro 404-728-7680

Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago,  Illinois,  60611-4494
United States
Recruiting Timothy  Kuzel 312-469-3748

Veterans Affairs Medical Center - Omaha *Recruiting*
Omaha,  Nebraska,  68105
United States
Recruiting James  Mailliard 402-280-5274

MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque,  New Mexico,  87131
United States
Recruiting Cynthia  Cathcart 505-272-5688

NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City,  New York,  10016
United States
Recruiting Howard  Hochster 212-652-1912

CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver,  Colorado,  80224
United States
Recruiting Eduardo  Pajon 303-777-2663

San Juan City Hospital *Recruiting*
San Juan,  ,  00936-7344
Puerto Rico
Recruiting Luis  Baez-Diaz 787-641-3693

Tufts - New England Medical Center *Recruiting*
Boston,  Massachusetts,  02111
United States
Recruiting John  Erban 617-636-5147

MetroHealth Medical Center *Recruiting*
Cleveland,  Ohio,  44109
United States
Recruiting Edward  Mansour 216-778-4394

Mercy Cancer Center at Mercy Medical Center-Des Moines *Recruiting*
Des Moines,  Iowa,  50314
United States
Recruiting Roscoe  Morton 515-247-3121

Indiana University Cancer Center *Recruiting*
Indianapolis,  Indiana,  46202-5289
United States
Recruiting Patrick  Loehrer 317-278-7418

Veterans Affairs Medical Center - San Juan *Recruiting*
San Juan,  ,  00927-5800
Puerto Rico
Recruiting Luis  Baez-Diaz 787-641-3693

Veterans Affairs Medical Center - Palo Alto *Recruiting*
Palo Alto,  California,  94304-1290
United States
Recruiting Harlan  Pinto 650-493-5000 ext. 4948

Veterans Affairs Medical Center - East Orange *Recruiting*
East Orange,  New Jersey,  07019
United States
Recruiting Basil  Kasimis 973-676-1000 ext. 1544

Veterans Affairs Medical Center - Tampa (Haley) *Recruiting*
Tampa,  Florida,  33612
United States
Recruiting Julie  Kish 813-972-2000

CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids,  Iowa,  52403-1206
United States
Recruiting Martin  Wiesenfeld 319-363-8303

CCOP - Carle Cancer Center *Recruiting*
Urbana,  Illinois,  61801
United States
Recruiting Kendrith  Rowland 217-383-4083

CCOP - Illinois Oncology Research Association *Recruiting*
Peoria,  Illinois,  61602
United States
Recruiting John  Kugler 309-636-3605

Drexel University Hospital *Recruiting*
Philadelphia,  Pennsylvania,  19102-1192
United States
Recruiting Pamela  Crilley 215-762-8547

Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee,  Wisconsin,  53226-3596
United States
Recruiting David  Vesole 414-805-4646

CCOP - Kalamazoo *Recruiting*
Kalamazoo,  Michigan,  49007-3731
United States
Recruiting Raymond  Lord 269-373-7488

University of Minnesota Cancer Center *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting George  Adams 612-625-2410

Veterans Affairs Medical Center - Gainesville *Recruiting*
Gainesville,  Florida,  32608-1197
United States
Recruiting Dean  McCarley 352-374-6016

CCOP - Columbus *Recruiting*
Columbus,  Ohio,  43206
United States
Recruiting J.  Kuebler 614-488-2118

CCOP - Duluth *Recruiting*
Duluth,  Minnesota,  55805
United States
Recruiting Robert  Dalton 218-786-8364

Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting Al  Benson 312-695-1382

Veterans Affairs Medical Center - New York *Recruiting*
New York City,  New York,  10010
United States
Recruiting Howard  Hochster 212-652-1912

Mayo Clinic Cancer Center *Recruiting*
Rochester,  Minnesota,  55905
United States
Recruiting Thomas  Habermann 507-284-2511

Veterans Affairs Medical Center - Indianapolis (Roudebush) *Recruiting*
Indianapolis,  Indiana,  46202
United States
Recruiting Patrick  Loehrer 317-554-0000

Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis,  Minnesota,  55417-2399
United States
Recruiting Markus  Gapany 612-725-2000 ext. 3459

CCOP - Toledo Community Hospital *Recruiting*
Toledo,  Ohio,  43623-3456
United States
Recruiting Paul  Schaefer 419-843-6147

University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham,  Alabama,  35294-3300
United States
Recruiting Carla  Falkson 205-975-2691

Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon,  New Hampshire,  03756-0002
United States
Recruiting Camilo  Fadul 603-650-6312

MBCCOP - San Juan *Recruiting*
San Juan,  ,  00921-3201
Puerto Rico
Recruiting Luis  Baez-Diaz 787-641-3693

Veterans Affairs Medical Center - Brooklyn *Recruiting*
Brooklyn,  New York,  11209
United States
Recruiting Andrea  Wiesel Leaf 718-630-3691

Pretoria Academic Hospital *Recruiting*
Pretoria,  ,  0001
South Africa
Recruiting Coenraad  Slabber 27-12-354-1054

CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend,  Indiana,  46601
United States
Recruiting Rafat  Ansari 574-284-7977

Albert Einstein Clinical Cancer Center *Recruiting*
Bronx,  New York,  10461
United States
Recruiting Joseph  Sparano 718-904-2555

Winship Cancer Institute of Emory University *Recruiting*
Atlanta,  Georgia,  30322
United States
Recruiting William  Wood 404-778-5180

Westmead Hospital *Recruiting*
Westmead,  New South Wales,  2145
Australia
Recruiting Richard  Kefford 61-2-9845-6033

MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx,  New York,  10466
United States
Recruiting Peter  Wiernik 718-920-1100

CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville,  Pennsylvania,  17822-2001
United States
Recruiting Suresh  Nair 570-271-6413

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus *Recruiting*
Nashville,  Tennessee,  37212-2637
United States
Recruiting Kenneth  Hande 615-327-4751

CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay,  Wisconsin,  54307-3453
United States
Recruiting Gerald  Bayer 920-433-8889

CCOP - Evanston *Recruiting*
Evanston,  Illinois,  60201
United States
Recruiting Gershon  Locker 847-570-2518

CCOP - Metro-Minnesota *Recruiting*
St. Louis Park,  Minnesota,  55416
United States
Recruiting Patrick  Flynn 952-993-15175

CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines,  Iowa,  50309-1016
United States
Recruiting Roscoe  Morton 515-244-7586

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville,  Tennessee,  37232-6307
United States
Recruiting David  Johnson 615-343-9454

CCOP - Christiana Care Health Services *Recruiting*
Newark,  Delaware,  19713
United States
Recruiting Stephen  Grubbs 302-623-4100

CCOP - Merit Care Hospital *Recruiting*
Fargo,  North Dakota,  58122
United States
Recruiting Preston  Steen 701-234-6161

Instituto de Enfermedades Neoplasicas *Recruiting*
Lima,  ,  34
Peru
Recruiting Carlos  Vallejos-Sologuren 51-14-499-137

CCOP - Scott and White Hospital *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Lucas  Wong 254-724-7048

CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls,  South Dakota,  57104
United States
Recruiting Loren  Tschetter 605-328-8044

Veterans Affairs Medical Center - Madison *Recruiting*
Madison,  Wisconsin,  53705
United States
Recruiting Mark  Albertini 608-262-7017

H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa,  Florida,  33612-9497
United States
Recruiting Cancer  Answers 800-456-7121


Additional Information:
Study ID Numbers:
  CDR0000334470;  ECOG-1499
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070447

Other Contiguous Stage 2 Mantle Cell Lymphoma Studies:
1. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

2. Bortezomib in Treating Patients With Mantle Cell Lymphoma

3. Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

4. Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

5. Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma

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

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