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Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma Clinical research trials and Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma. Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma clinical trial. Test subjects typically obtain the finest healthcare available for their Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma  Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
For Condition: stage 2 mantle cell lymphoma,stage 3 mantle cell lymphoma,stage 4 mantle cell lymphoma
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining rituximab with chemotherapy may kill more cancer cells. PURPOSE: Phase IIpilot study to study the effectiveness of combining chemotherapy with rituximab in treating patients who have newly diagnosed mantle cell lymphoma.
Details: OBJECTIVES: - Determine the 1-year progression-free survival probability in patients with previously untreated mantle cell lymphoma treated with courses of rituximab and cyclophosphamide, doxorubicin, vincristine, and dexamethasone alternating with courses of rituximab and high-dose cytarabine and methotrexate with leucovorin calcium. - Determine the response rate (complete unconfirmed and complete and partial responses), and survival of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. - Correlate chromosomal breakpoints, translocated immunoglobulin regulatory sequences, and cyclins D1, D2, and D3 with response and progression-free survival in patients treated with this regimen. - Correlate gene expression (measured by DNA microarray analysis) with response and progression-free survival in patients treated with this regimen. OUTLINE: This is a multicenter study. - Courses 1, 3, 5, and 7: Patients receive rituximab IV on day 1 (courses 1, 3, and 5 only); cyclophosphamide IV over 3 hours twice a day on days 2-4; doxorubicin IV over 24 hours on days 5-7; vincristine IV on days 5 and 12; dexamethasone orally or IV four times a day on days 2-5 and 12-15; and filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 8 and continuing until blood counts recover. - Courses 2, 4, 6, and 8: Patients receive rituximab IV on day 1 (courses 2, 4, and 6 only); methotrexate IV over 24 hours on day 2; cytarabine IV over 2 hours twice a day on days 3-4; oral leucovorin calcium 4 times a day on days 3-10; and G-CSF SC daily beginning on day 5 and continuing until blood counts recover. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 25 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/69 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven stage III/IV or bulky stage II mantle cell lymphoma of one of the following histologic subtypes: - Nodular - Diffuse - Mantle zone - Blastic - Newly diagnosed and previously untreated disease - Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: - 18 to 69 Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 (50,000/mm^3 if marrow involvement present) - Circulating lymphoid cells less than 5,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL (5.0 mg/dL if hepatic involvement present) Renal: - Creatinine no greater than 2.0 mg/dL* - Creatinine clearance greater than 50 mL/min* NOTE: *Unless hepatic involvement present Cardiovascular: - Ejection fraction at least 50% by MUGA - No significant abnormalities by EKG Other: - Not pregnant or nursing - Fertile patients must use effective contraception - Willing to receive blood product transfusions - No known sensitivity to E. coli-derived proteins - No known AIDS syndrome or HIV-associated complex - No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior monoclonal antibody therapy Chemotherapy: - No prior chemotherapy for lymphoma Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy for lymphoma Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ElliotEpner, Study Chair, Oregon Health and Science University
Veterans Affairs Medical Center - Albuquerque *Recruiting*
Albuquerque, New Mexico, 87108-5138
United States
Recruiting Douglas Clark 505-243-4039
Tulane University School of Medicine *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Alan Miller 504-587-7566
CCOP - Santa Rosa Memorial Hospital *Recruiting*
Santa Rosa, California, 95403
United States
Recruiting Ian Anderson 707-521-3859
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Carolyn Reed 843-792-3362
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-2046
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-0269
United States
Recruiting Kim Margolin 626-359-8111
Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130-3932
United States
Recruiting Glenn Mills 318-675-7639
Veterans Affairs Medical Center - Jackson *Recruiting*
Jackson, Mississippi, 39216
United States
Recruiting James Thigpen 601-362-4471
Veterans Affairs Medical Center - Temple *Recruiting*
Temple, Texas, 76504
United States
Recruiting Phalguni Mukhopadhyay 254-778-4811 ext. 4809
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
University of Tennessee Cancer Institute *Recruiting*
Memphis, Tennessee, 38103
United States
Recruiting Mohammad Jahanzeb 901-722-0532
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Daniel Petrylak 212-305-1731
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
Cancer Research Center at Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Douglas Faller 617-638-8000
Veterans Affairs Medical Center - Charleston *Recruiting*
Charleston, South Carolina, 29401-5799
United States
Recruiting Andrew Turrisi 843-792-273
Veterans Affairs Medical Center - Ann Arbor *Recruiting*
Ann Arbor, Michigan, 48105
United States
Recruiting Laurence Baker 734-769-7100
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) *Recruiting*
Phoenix, Arizona, 85012
United States
Recruiting Thomas Kummet 602-277-5551
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting John Barstis 310-825-5268
Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle, Washington, 98108
United States
Recruiting William Schubach 206-764-2265
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195-9001
United States
Recruiting George Budd 216-444-6480
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Richard Fisher 585-275-0842
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97201-3098
United States
Recruiting Craig Nichols 503-494-6346
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7353
United States
Recruiting Sarah Taylor 913-588-6029
Veterans Affairs Medical Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130
United States
Recruiting Glenn Mills 318-221-8411
Veterans Affairs Medical Center - Dayton *Recruiting*
Dayton, Ohio, 45428-1002
United States
Recruiting Howard Gross 937-268-6511
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
Brooke Army Medical Center *Recruiting*
Fort Sam Houston, Texas, 78234-6200
United States
Recruiting Mitchell Garrison 210-916-0504
CCOP - St. Louis-Cape Girardeau *Recruiting*
St. Louis, Missouri, 63141
United States
Recruiting Patrick Henry 314-569-6573
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting David Gandara 916-734-3772
Veterans Affairs Medical Center - New Orleans *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Alan Miller 504-589-5250
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting James Thigpen 601-984-5590
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Randall Holcombe 714-456-5153
Veterans Affairs Medical Center - Albany *Recruiting*
Albany, New York, 12208
United States
Recruiting James Holland 518-462-3311 ext. 2328
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4095
United States
Recruiting Scott Lippman 713-745-3672
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0501
United States
Recruiting Abdul-Rahman Jazieh 513-584-3830
CCOP - Atlanta Regional *Recruiting*
Atlanta, Georgia, 30342-1701
United States
Recruiting Thomas Seay 404-851-2340
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112-5550
United States
Recruiting Wolfram Samlowski 801-585-0255
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Robert Chapman 313-916-1850
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0912
United States
Recruiting Laurence Baker 734-936-3983
Veterans Affairs Medical Center - Tucson *Recruiting*
Tucson, Arizona, 85723
United States
Recruiting Thomas Miller 520-792-1450 ext. 16631
CCOP - Beaumont *Recruiting*
Royal Oak, Michigan, 48073-6769
United States
Recruiting David Decker 248-551-7695
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0084
United States
Recruiting Michael Doukas 859-257-4500
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
Veterans Affairs Medical Center - Cincinnati *Recruiting*
Cincinnati, Ohio, 45220-2288
United States
Recruiting Abdul-Rahman Jazieh 513-861-3100 ext. 6537
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Geoffrey Weiss 210-617-5120
Providence Cancer Institute at Providence Hospital *Recruiting*
Southfield, Michigan, 48075
United States
Recruiting Anibal Drelichman 313-552-0620
Danville Radiation Therapy Center *Recruiting*
Memphis, Tennessee, 38104
United States
Recruiting Mohammad Jahanzeb 901-523-8990
Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Thomas Miller 520-626-2667
Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting William Robinson 806-355-9703
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) *Recruiting*
Hines, Illinois, 60141
United States
Recruiting Nirmala Bhoopalam 708-202-2782
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1461
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Laura Hutchins 501-686-8511
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153-5500
United States
Recruiting Patrick Stiff 708-327-3148
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Lawrence Flaherty 313-745-9155
David Grant Medical Center *Recruiting*
Travis Air Force Base, California, 94535
United States
Recruiting David Gandara 707-423-7300
Veterans Affairs Medical Center - Kansas City *Recruiting*
Kansas City, Missouri, 64128
United States
Recruiting Sarah Taylor 816-861-4700 ext. 491
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
CCOP - Bay Area Tumor Institute *Recruiting*
Oakland, California, 94609-3305
United States
Recruiting Joseph Szumowski 510-465-8570
CCOP - Virginia Mason Research Center *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Andrew Jacobs 206-341-0446
Veterans Affairs Medical Center - Lexington *Recruiting*
Lexington, Kentucky, 40502-2236
United States
Recruiting Michael Doukas 859-281-4956
St. Louis University Hospital Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Paul Petruska 314-577-8854
Veterans Affairs Medical Center - San Antonio (Murphy) *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Geoffrey Weiss 210-617-5120
Harrington Cancer Center *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting James Clarkson 806-359-4673
Veterans Affairs Medical Center - Detroit *Recruiting*
Detroit, Michigan, 48201-1932
United States
Recruiting Lawrence Flaherty 313-576-1000
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
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 - Oklahoma City *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-270-0501
Veterans Affairs Medical Center - Salt Lake City *Recruiting*
Salt Lake City, Utah, 84148
United States
Recruiting Wolfram Samlowski 801-582-1565
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Anthony Elias 720-848-1622
Veterans Affairs Medical Center - Portland *Recruiting*
Portland, Oregon, 97207
United States
Recruiting Craig Nichols 503-220-8262
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
Madigan Army Medical Center *Recruiting*
Tacoma, Washington, 98431-5000
United States
Recruiting Rajat Bannerji 253-968-2504
CCOP - Montana Cancer Consortium *Recruiting*
Billings, Montana, 59101
United States
Recruiting Patrick Cobb 406-259-2245
Veterans Affairs Medical Center - Houston *Recruiting*
Houston, Texas, 77030
United States
Recruiting Gauri Varadhachary 713-791-1414 ext. 5340
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0565
United States
Recruiting Robert Whitehead 409-772-1164
Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita, Kansas, 67218
United States
Recruiting Shaker Dakhil 316-685-2221
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cheryl Willman 505-272-5837
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
Veterans Affairs Medical Center - Little Rock (McClellan) *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Bart Barlogie 501-526-2873
Veterans Affairs Outpatient Clinic - Martinez *Recruiting*
Martinez, California, 94553
United States
Recruiting David Gandara 925-372-2064
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Heinz-Josef Lenz 323-865-3955
Additional Information:
Study ID Numbers: CDR0000069445; SWOG-S0213
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041132
Other Stage 2 Mantle Cell Lymphoma Studies:
1. Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
2. Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
3. Combination Chemotherapy With or Without Rituximab in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma
Related Studies:
Other stage 2 mantle cell lymphoma Clinical Trials
Other South Carolina Clinical Trials
Other Charleston Clinical Trials
Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
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