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Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: July 8, 2005   Last Updated: November 25, 2009   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118209
  Purpose

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: filgrastim
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: prednisone
Drug: vincristine sulfate
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival 5 years after completion of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • R-CHOP and DA-EPOCH-R molecular predictors of outcome as measured by cDNA microarray 5 years after completion of study treatment [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: May 2005
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I (R-CHOP): Active Comparator
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin IV over 3-5 minutes, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Biological: rituximab
Given IV
Drug: cyclophosphamide
Prednisone given orally; all others given IV
Drug: doxorubicin hydrochloride
Prednisone given orally; all others given IV
Drug: prednisone
Prednisone given orally; all others given IV
Drug: vincristine sulfate
Prednisone given orally; all others given IV
Arm II (EPOCH-R): Experimental
Patients receive rituximab IV on day 1, doxorubicin IV, etoposide IV, and vincristine IV continuously over 96 hours on days 1-4, cyclophosphamide IV on day 5, and oral prednisone twice daily on days 1-5. Patients also receive filgrastim (G-CSF) once daily on days 2-11 or until blood counts recover. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Biological: filgrastim
No administration information available
Biological: rituximab
Given IV
Drug: cyclophosphamide
Prednisone given orally; all others given IV
Drug: doxorubicin hydrochloride
Prednisone given orally; all others given IV
Drug: etoposide
Given IV
Drug: prednisone
Prednisone given orally; all others given IV
Drug: vincristine sulfate
Prednisone given orally; all others given IV

Detailed Description:

OBJECTIVES:

Primary

  • Compare the event-free survival of patients with previously untreated de novo diffuse large B-cell non-Hodgkin's lymphoma treated with R-CHOP comprising rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone vs EPOCH-R comprising etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab.
  • Determine molecular predictors of outcome (using molecular profiling) in patients treated with these regimens.

Secondary

  • Compare the response rate and overall survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Correlate the clinical parameters (i.e., toxicity, response, survival outcomes, and laboratory results) with molecular profiling in patients treated with these regimens.
  • Determine the use of molecular profiling for pathological diagnosis in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Index score. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (R-CHOP): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin IV over 3-5 minutes, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II (EPOCH-R): Patients receive rituximab IV on day 1, doxorubicin IV, etoposide IV, and vincristine IV continuously over 96 hours on days 1-4, cyclophosphamide IV on day 5, and oral prednisone twice daily on days 1-5. Patients also receive filgrastim (G-CSF) once daily on days 2-11 or until blood counts recover. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 478 patients (239 per treatment arm) will be accrued for this study within 4.5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed* de novo B-cell non-Hodgkin's lymphoma (NHL) of 1 of the following WHO histologic subtypes:

    • Diffuse large cell lymphoma, including any of the following morphologic variants:

      • Centroblastic
      • Immunoblastic
      • T-cell/histiocyte rich
      • Anaplastic
    • Mediastinal (thymic) large cell lymphoma
    • Intravascular large cell lymphoma NOTE: *Fine needle aspirates or core biopsies must not be the only diagnostic material
  • Stage I primary mediastinal (thymic) OR stage II-IV disease
  • CD20-positive disease
  • No underlying low-grade lymphoma (e.g., transformed lymphoma or low-grade lymphoma in the bone marrow)
  • No known lymphomatous CNS involvement

    • Lumbar puncture required unless there are no neurological symptoms NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3^*
  • Platelet count ≥ 100,000/mm^3^*
  • No active bleeding unrelated to NHL NOTE: *Unless due to NHL

Hepatic

  • Bilirubin ≤ 2 mg/dL* NOTE: *Unless due to NHL or Gilbert's disease

Renal

  • Creatinine ≤ 1.5 mg/dL^* OR
  • Creatinine clearance ≥ 50 mL/min^* NOTE: *Unless due to NHL

Cardiovascular

  • No active ischemic heart disease
  • No congestive heart failure

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No active uncontrolled bacterial or viral infection unrelated to NHL
  • No other active medical process unrelated to NHL

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior rituximab

Chemotherapy

  • No prior chemotherapy for other malignancies
  • No prior cytotoxic chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Prior short course (< 10 days) glucocorticoids allowed for an urgent local disease complication (e.g., cord compression or superior vena cava syndrome) at diagnosis
  • No concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease related conditions (e.g., insulin for diabetes)
  • No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy

  • Prior limited field radiotherapy allowed for an urgent local disease complication (e.g., cord compression or superior vena cava syndrome) at diagnosis
  • No concurrent radiotherapy except for isolated CNS lesions

Surgery

  • Not specified

Other

  • No other concurrent investigational or commercial agents or therapies for NHL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118209

  Hide Study Locations
Locations
United States, Alabama
Regional Medical Center Recruiting
Anniston, Alabama, United States, 36202
Contact: Pramod A. Vadlamani     256-235-5877        
United States, Alaska
Providence Cancer Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Clinical Trials Office - Providence Cancer Center     907-261-3109        
United States, California
Camino Medical Group - Treatment Center Recruiting
Mountain View, California, United States, 94040
Contact: Peter P. Yu, MD     408-524-5814        
Desert Regional Medical Center Comprehensive Cancer Center Recruiting
Palm Springs, California, United States, 92262
Contact: Clinical Trials Office - Desert Regional Medical Center Compre     760-416-4730        
Providence Saint Joseph Medical Center - Burbank Recruiting
Burbank, California, United States, 91505
Contact: Clinical Trials Office - Providence Saint Joseph Medical Cente     818-847-3220        
Naval Medical Center - San Diego Recruiting
San Diego, California, United States, 92134
Contact: Preston S. Gable, MD, FACP     619-532-7319        
Palo Alto Medical Foundation Recruiting
Palo Alto, California, United States, 94301
Contact: David S. Leibowitz     650-321-4121        
Glendale Memorial Hospital Comprehensive Cancer Center Recruiting
Glendale, California, United States, 91204
Contact: Clinical Trials Office - Glendale Memorial Hospital Comprehens     818-409-7653        
United States, Colorado
Aurora Presbyterian Hospital Recruiting
Aurora, Colorado, United States, 80012
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Boulder Community Hospital Recruiting
Boulder, Colorado, United States, 80301-9019
Contact: Clinical Trials Office - Boulder Community Hospital     303-938-5253        
CCOP - Colorado Cancer Research Program Recruiting
Denver, Colorado, United States, 80224-2522
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
St. Anthony Central Hospital Recruiting
Denver, Colorado, United States, 80204
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Hope Cancer Care Center at Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
McKee Medical Center Recruiting
Loveland, Colorado, United States, 80539
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Memorial Hospital Cancer Center - Colorado Springs Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Clinical Trials Office - Memorial Hospital     719-365-2406        
North Colorado Medical Center Recruiting
Greeley, Colorado, United States, 80631
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
North Suburban Medical Center Recruiting
Thornton, Colorado, United States, 80229
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Penrose Cancer Center at Penrose Hospital Recruiting
Colorado Springs, Colorado, United States, 80933
Contact: Clinical Trials Office - Penrose Cancer Center     719-776-5275        
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Presbyterian - St. Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen     303-839-6000        
Rose Medical Center Recruiting
Denver, Colorado, United States, 80220
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Sky Ridge Medical Center Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Exempla Lutheran Medical Center Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact: Clinical Trials Office - Exempla Lutheran Medical Center     303-403-3605        
St. Joseph Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
St. Mary - Corwin Regional Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Recruiting
Grand Junction, Colorado, United States, 81502
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80110
Contact: Eduardo R. Pajon, MD     303-399-8020ext2261        
United States, Connecticut
Eastern Connecticut Hematology and Oncology Associates Recruiting
Norwich, Connecticut, United States, 06360
Contact: Dennis E. Slater, MD     860-886-8362        
Helen and Harry Gray Cancer Center at Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102-5037
Contact: Clinical Trials Office - Helen and Harry Gray Cancer Center     860-545-5363        
United States, Delaware
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services     302-733-6227        
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center     302-645-3171        
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center     202-444-0381        
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Bruce R. Kressel, MD, FACP     202-293-5382        
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307-5001
Contact: Clinical Trials Office - Walter Reed Army Medical Center     202-782-7840        
Washington Cancer Institute at Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Clinical Trials Office - Washington Cancer Institute     202-877-8839        
United States, Florida
CCOP - Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Rogerio C. Lilenbaum, MD     305-535-3310        
Cleveland Clinic Florida - Weston Recruiting
Weston, Florida, United States, 33331
Contact: Clinical Trials Office - Cleveland Clinic Florida - Weston     954-659-5705        
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Recruiting
Jupiter, Florida, United States, 33458
Contact: Clinical Trials Office - Ella Milbank Foshay Cancer Center     561-745-5768        
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Clinical Trials Office - Michael and Dianne Bienes Comprehensi     954-776-3239        
United States, Georgia
Augusta Oncology Associates - Walton Way Recruiting
Augusta, Georgia, United States, 30901
Contact: Contact Person     706-821-2944        
Medical Center of Central Georgia Recruiting
Macon, Georgia, United States, 31208
Contact: Frederick M. Schnell, MD, FACP     478-743-7068        
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: O. George Negrea, MD     912-692-2000        
United States, Illinois
Cancer Care and Hematology Specialists of Chicagoland - Niles Recruiting
Niles, Illinois, United States, 60714
Contact: Jane N. Winter, MD     312-695-4538        
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center     708-226-4357        
Decatur Memorial Hospital Cancer Care Institute Recruiting
Decatur, Illinois, United States, 62526
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care     217-876-6601        
Hematology and Oncology Associates Recruiting
Chicago, Illinois, United States, 60611
Contact: Clinical Trails Office - Hematology and Oncology Associates     312-695-1301        
Hematology Oncology Associates - Skokie Recruiting
Skokie, Illinois, United States, 60076
Contact: Jane N. Winter, MD     312-695-4538        
Hematology Oncology Associates of Illinois - Berwyn Recruiting
Berwyn, Illinois, United States, 60402
Contact: Jane N. Winter, MD     312-695-4538        
Hematology Oncology Consultants - Naperville Recruiting
Naperville, Illinois, United States, 60540
Contact: Fariborze B. Barhamand, MD     630-369-1501        
Joliet Oncology-Hematology Associates, Limited - West Recruiting
Joliet, Illinois, United States, 60435
Contact: Sanjiv S. Modi     815-730-3098        
La Grange Oncology Associates - Geneva Recruiting
Naperville, Illinois, United States, 60563
Contact: Jane N. Winter, MD     312-695-4538        
Midwest Center for Hematology/Oncology Recruiting
Joliet, Illinois, United States, 60432
Contact: Jane N. Winter, MD     312-695-4538        
North Shore Oncology and Hematology Associates, Limited - Libertyville Recruiting
Libertyville, Illinois, United States, 60048
Contact: Jane N. Winter, MD     312-695-4538        
Regional Cancer Center at Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me     217-788-4233        
Resurrection Medical Center Recruiting
Chicago, Illinois, United States, 60631
Contact: Christopher G. Rose, MD     847-965-3200        
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
Swedish Covenant Hospital Recruiting
Chicago, Illinois, United States, 60625
Contact: K. Joseph Philip, MD     773-784-6676        
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612-7243
Contact: Clinical Trial Office - University of Illinois Cancer Center     312-355-3046        
United States, Indiana
Community Hospital Recruiting
Munster, Indiana, United States, 46321
Contact: Erwin L. Robin, MD     219-836-2860        
Fort Wayne Medical Oncology and Hematology Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Sreenivasa R. Nattam, MD     260-484-8830        
United States, Iowa
Cedar Rapids Oncology Associates Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Clinical Trials Office - Cedar Rapids Oncology Associates     319-363-2690        
McCreery Cancer Center at Ottumwa Regional Recruiting
Ottumwa, Iowa, United States, 52501
Contact: Robert J. Behrens     641-684-2946        
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC     515-239-2621        
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD     712-252-0088        
Mercy Regional Cancer Center at Mercy Medical Center Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Martin Wiesenfeld, MD     319-363-8303        
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD     712-252-0088        
St. Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD     712-252-0088        
United States, Kansas
Cotton-O'Neil Cancer Center Recruiting
Topeka, Kansas, United States, 66606
Contact: Clinical Trials Office - Cotton-O'Neil Cancer Center     785-270-4963        
St. Francis Comprehensive Cancer Center Recruiting
Topeka, Kansas, United States, 66606
Contact: Stanley J. Vogel, MD     785-354-0544        
United States, Kentucky
James Graham Brown Cancer Center at University of Louisville Recruiting
Louisville, Kentucky, United States, 40292
Contact: Roger H. Herzig     502-562-4158        
United States, Maine
MaineGeneral Medical Center - Waterville Recruiting
Waterville, Maine, United States, 04901
Contact: Clinical Trials Office - MaineGeneral Medical Center - Watervi     207-872-1792        
United States, Maryland
Associates in Oncology and Hematology - Medical Center Drive Recruiting
Rockville, Maryland, United States, 20878
Contact: Paul M. Thambi     301-424-6231        
Associates in Oncology and Hematology Recruiting
Kensington, Maryland, United States, 20895
Contact: Paul M. Thambi     301-929-0765        
Greenebaum Cancer Center at University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit     800-888-8823        
NIH - Warren Grant Magnuson Clinical Center Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - NIH - Warren Grant Magnuson Clinical     800-411-1222        
Union Hospital Cancer Program at Union Hospital Recruiting
Elkton Md, Maryland, United States, 21921
Contact: Stephen S. Grubbs, MD     302-366-1200        
United States, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Clinical Trials Office     617-724-5200        
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jeremy S. Abramson     617-632-3474        
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital     877-726-5130        
United States, Michigan
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD     269-373-7458        
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord, MD     269-373-7458        
Dickinson County Healthcare System Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Green Bay Oncology, Limited - Escanaba Recruiting
Escanaba, Michigan, United States, 49431
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Providence Cancer Institute at Providence Hospital - Southfield Campus Recruiting
Southfield, Michigan, United States, 48075
Contact: Howard R. Terebelo, DO     248-552-0620        
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center     269-373-7458        
United States, Minnesota
Veterans Affairs Medical Center - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Min     612-467-2800        
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia Recruiting
Columbia, Missouri, United States, 65203
Contact: Clinical Trial Office - Ellis Fischel Cancer Center     573-882-7440        
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Nancy L. Bartlett, MD     314-362-5654        
United States, Montana
Big Sky Oncology Recruiting
Great Falls, Montana, United States, 59405-5309
Contact: Clinical Trail Office - Big Sky Oncology     406-731-8217        
Great Falls Clinic - Main Facility Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD     406-238-6290        
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD     406-238-6290        
CCOP - Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Community Medical Center Recruiting
Missoula, Montana, United States, 59801
Contact: Benjamin T. Marchello, MD     406-238-6290        
Glacier Oncology, PLLC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown     800-996-2663     research@billingsclinic.org    
Guardian Oncology and Center for Wellness Recruiting
Missoula, Montana, United States, 59804
Contact: Benjamin T. Marchello, MD     406-238-6290        
Hematology-Oncology Centers of the Northern Rockies - Billings Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Kalispell Medical Oncology at KRMC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD     406-238-6290        
Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD     406-238-6290        
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Recruiting
Missoula, Montana, United States, 59807
Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick     406-329-7029        
St. Peter's Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello, MD     406-238-6290        
Northern Montana Hospital Recruiting
Havre, Montana, United States, 59501
Contact: Benjamin T. Marchello, MD     406-238-6290        
Northern Rockies Radiation Oncology Center Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
Sletten Cancer Institute at Benefis Healthcare Recruiting
Great Falls, Montana, United States, 59405
Contact: Grant W. Harrer, MD, FACP, CCTI     406-731-8100        
St. James Healthcare Cancer Care Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello, MD     406-238-6290        
Montana Cancer Specialists at Montana Cancer Center Recruiting
Missoula, Montana, United States, 59807-7877
Contact: Clinical Trials Office - Montana Cancer Specialists at Montana     406-238-6962        
St. Vincent Healthcare Cancer Care Services Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD     406-238-6290        
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital Recruiting
Kearney, Nebraska, United States, 68848-1990
Contact: Clinical Trials Office - Good Samaritan Cancer Center at Good     308-865-7963        
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Robert M. Langdon, MD     402-399-8762        
United States, Nevada
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton, MD, CM     702-384-0013        
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: John A. Ellerton, MD, CM     702-384-0013        
United States, New Hampshire
Elliot Regional Cancer Center at Elliot Hospital Recruiting
Manchester, New Hampshire, United States, 03103
Contact: Douglas J. Weckstein, MD     603-622-6484        
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo     856-325-6757        
CCOP - Northern New Jersey Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Andre Goy     201-996-5834        
United States, New Mexico
Lovelace Medical Center - Downtown Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Edward N. Libby     505-727-8000        
University of New Mexico Cancer Center - South Recruiting
Las Cruces, New Mexico, United States, 88011
Contact: Edward N. Libby     505-521-1554        
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente     505-272-6972        
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe     718-904-2730     aecc@aecom.yu.edu    
Charles R. Wood Cancer Center at Glens Falls Hospital Recruiting
Glens Falls, New York, United States, 12801
Contact: Clinical Trials Office - Charles R. Wood Cancer Center at Glen     518-926-6700        
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Luis M. Isola, MD     212-241-6021        
New York Weill Cornell Cancer Center at Cornell University Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center     212-746-1848        
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute     877-275-7724        
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi     315-464-5476        
United States, North Carolina
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD     252-559-2200ext.201        
Southeastern Medical Oncology Center - Goldsboro Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     osu@emergingmed.com    
Aultman Cancer Center at Aultman Hospital Recruiting
Canton, Ohio, United States, 44710-1799
Contact: Clinical Trials Office - Aultman Cancer Center at Aultman Hosp     330-363-6891        
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center     800-641-2422        
McDowell Cancer Center at Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Esther H. Rehmus, MD     330-344-6505        
MetroHealth Cancer Care Center at MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Bruce J. Averbook, MD, FACS     216-778-4795        
St. Rita's Medical Center Recruiting
Lima, Ohio, United States, 45801
Contact: Clinical Trials Office - St. Rita's Medical Center     419-226-9617        
United States, Pennsylvania
Easton Regional Cancer Center at Easton Hospital Recruiting
Easton, Pennsylvania, United States, 18042
Contact: Rajen P. Oza     610-250-4567        
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce     570-271-5251        
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute     570-271-5251        
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224-1791
Contact: John Lister     412-578-5000        
Geisinger Medical Group - Scenery Park Recruiting
State College, Pennsylvania, United States, 16801
Contact: Adel Z. Makary, MD     570-271-6045        
Hematology and Oncology Associates of Northeastern Pennsylvania Recruiting
Scranton, Pennsylvania, United States, 18510
Contact: Martin B. Hyzinski, MD     570-558-3020        
Mercy Hospital Cancer Center - Scranton Recruiting
Scranton, Pennsylvania, United States, 18501
Contact: Martin B. Hyzinski, MD     570-558-3020        
Mount Nittany Medical Center Recruiting
State College, Pennsylvania, United States, 16803
Contact: Philip A. Lowry, MD     978-343-5048        
Geisinger Hazleton Cancer Center Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Adel Z. Makary, MD     570-271-6045        
United States, Rhode Island
Memorial Hospital of Rhode Island Recruiting
Pawtucket, Rhode Island, United States, 02860
Contact: Humera Khurshid     401-729-2000        
United States, South Dakota
Medical X-Ray Center, PC Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Loren K. Tschetter, MD     605-328-8000        
Sanford Cancer Center at Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117-5039
Contact: Clinical Trials Office - Sanford Cancer Center     605-328-1367        
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus Recruiting
Burlington, Vermont, United States, 05401
Contact: Clinical Trials Office - Fletcher Allen Health Care     802-656-8990        
Mountainview Medical Recruiting
Berlin, Vermont, United States, 05602
Contact: Barbara W. Grant, MD     802-847-8400        
United States, Virginia
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298-0037
Contact: Clinical Trials Office -Virginia Commonwealth University Masse     804-628-1939        
United States, Washington
Allenmore Hospital Recruiting
Tacoma, Washington, United States, 98405
Contact: Lauren K. Colman, MD     253-403-1677        
Auburn Regional Center for Cancer Care Recruiting
Auburn, Washington, United States, 98002
Contact: Lauren K. Colman, MD     253-403-1677        
Cancer Care Northwest - Spokane South Recruiting
Spokane, Washington, United States, 99202
Contact: Clinical Trials Office - Cancer Care Northwest - Spokane South     509-228-1083        
CCOP - Northwest Recruiting
Tacoma, Washington, United States, 98405
Contact: Lauren K. Colman, MD     253-403-1677        
Columbia Basin Hematology Recruiting
Kennewick, Washington, United States, 99336
Contact: Saul E. Rivkin, MD     206-386-2441        
Evergreen Hematology and Oncology, PS Recruiting
Spokane, Washington, United States, 99218
Contact: Saul E. Rivkin, MD     206-386-2441        
St. Francis Hospital Recruiting
Federal Way, Washington, United States, 98003
Contact: Lauren K. Colman, MD     253-403-1677        
Good Samaritan Cancer Center Recruiting
Puyallup, Washington, United States, 98372
Contact: Lauren K. Colman, MD     253-403-1677        
Group Health Central Hospital Recruiting
Seattle, Washington, United States, 98112
Contact: Clinical Trials Office - Group Health Central Hospital     206-287-2900        
Madigan Army Medical Center - Tacoma Recruiting
Tacoma, Washington, United States, 98431
Contact: Jasmine T. Daniels     253-968-2505ext.0746        
Minor and James Medical, PLLC Recruiting
Seattle, Washington, United States, 98104
Contact: Saul E. Rivkin, MD     206-386-2441        
MultiCare Regional Cancer Center at Tacoma General Hospital Recruiting
Tacoma, Washington, United States, 98405
Contact: Clinical Trials Office - MultiCare Regional Cancer Center     253-403-3229        
Olympic Hematology and Oncology Recruiting
Bremerton, Washington, United States, 98310
Contact: Saul E. Rivkin, MD     206-386-2441        
Polyclinic First Hill Recruiting
Seattle, Washington, United States, 98122
Contact: Saul E. Rivkin, MD     206-386-2441        
Providence Centralia Hospital Recruiting
Centralia, Washington, United States, 98531-9027
Contact: Clinical Trials Office - Providence Centralia H     360-493-4300        
Providence St. Peter Hospital Regional Cancer Center Recruiting
Olympia, Washington, United States, 98506-5166
Contact: Lauren K. Colman, MD     253-403-1677        
St. Clare Hospital Recruiting
Tacoma, Washington, United States, 98499
Contact: Lauren K. Colman, MD     253-403-1677        
Franciscan Cancer Center at St. Joseph Medical Center Recruiting
Tacoma, Washington, United States, 98405-3004
Contact: Clinical Trials Office - Franciscan Cancer Center     253-426-6914        
St. Joseph Cancer Center Recruiting
Bellingham, Washington, United States, 98225
Contact: Saul E. Rivkin, MD     206-386-2441        
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Recruiting
Seattle, Washington, United States, 98122-4307
Contact: Saul E. Rivkin, MD     206-386-2441        
University Cancer Center at University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195-6043
Contact: Clinical Trials Office - University Cancer Center at Universit     206-616-8289        
United States, West Virginia
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Recruiting
Huntington, West Virginia, United States, 25701
Contact: Oncology Research Supervisor     304-399-6617        
United States, Wisconsin
Bay Area Cancer Care Center at Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Green Bay Oncology, Limited - Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Marshfield Clinic - Indianhead Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Ali W. Bseiso, MD     715-387-5416        
Green Bay Oncology, Limited at St. Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center     608-775-2385     cancerctr@gundluth.org    
Marshfield Clinic - Chippewa Center Recruiting
Chippewa Falls, Wisconsin, United States, 54729
Contact: Ali W. Bseiso, MD     715-387-5416        
Green Bay Oncology, Limited - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
Marshfield Clinic - Lakeland Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Ali W. Bseiso, MD     715-387-5416        
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center     800-782-1581 ext. 94457        
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Ali W. Bseiso, MD     715-387-5416        
Marshfield Clinic - Wisconsin Rapids Center Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Ali W. Bseiso, MD     715-387-5416        
Marshfield Clinic Cancer Care at Regional Cancer Center Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Ali W. Bseiso, MD     715-387-5416        
Ministry Medical Group at Saint Mary's Hospital Recruiting
Rhinelander, Wisconsin, United States, 54501
Contact: Ali W. Bseiso, MD     715-387-5416        
Saint Joseph's Hospital Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Ali W. Bseiso, MD     715-387-5416        
Saint Michael's Hospital Cancer Center Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Ali W. Bseiso, MD     715-387-5416        
St. Mary's Hospital Medical Center - Green Bay Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Thomas J. Saphner, MD, FACP     920-884-3135        
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer     920-433-8889        
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo     608-262-5223        
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital Recruiting
Sheridan, Wyoming, United States, 82801
Contact: Benjamin T. Marchello, MD     406-238-6290        
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Wyndham H. Wilson, MD, PhD National Cancer Institute (NCI)
Investigator: Andrew D. Zelenetz, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Cancer and Leukemia Group B ( Richard L. Schilsky )
Study ID Numbers: CDR0000433265, CALGB-50303, ECOG-50303, NCI-05-C-0252
Study First Received: July 8, 2005
Last Updated: November 25, 2009
ClinicalTrials.gov Identifier: NCT00118209     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I adult diffuse large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones
Lymphoma, B-Cell
Therapeutic Uses
Lymphoma
Etoposide
Alkylating Agents
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Mitosis Modulators
Vincristine
Antimitotic Agents
Glucocorticoids
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases
Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009