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| 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 |
| 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
|
OBJECTIVES:
Primary
Secondary
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.
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 |
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:
No known lymphomatous CNS involvement
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study 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 | |
| Study Chair: | Wyndham H. Wilson, MD, PhD | National Cancer Institute (NCI) |
| Investigator: | Andrew D. Zelenetz, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
| 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 |
|
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 |
|
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 |