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| ID | Type | Description | Link |
|---|---|---|---|
| S9911 | Other Identifier | SWOG | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by monoclonal antibody therapy in treating patients who have newly diagnosed follicular non-Hodgkin's lymphoma.
OBJECTIVES: I. Determine the 2 year failure free survival rate of patients with newly diagnosed follicular lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) followed by iodine I 131 monoclonal antibody anti-B1. II. Determine the complete and partial response rates of these patients after this therapy. III. Evaluate the toxicity of this regimen in these patients. IV. Determine the rate of disappearance of cells with clonal t(14;18)/bcl2 rearrangements from the peripheral blood and bone marrow after this therapy in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment is repeated every 21 days for up to 6 courses. Within 4-8 weeks after the last course of chemotherapy, patients who achieve at least a partial response and have less than 25% bone marrow involvement begin immunotherapy. Patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV over 1 hour, then iodine I 131 MOAB anti-B1 IV over 20 minutes on day 1. This regimen is repeated on day 8. Patients are followed every 6 months for 2 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHOP regimen | Drug | |||
| cyclophosphamide | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| prednisone | Drug | |||
| vincristine sulfate | Drug | |||
| tositumomab and iodine I 131 tositumomab | Radiation |
DISEASE CHARACTERISTICS: Histologically confirmed follicular non-Hodgkin's lymphoma No prior treatment Bulky stage II, stage III, or stage IV Must express cluster of differentiation antigen 20 (CD20) antigen Bidimensionally measurable disease No Central Nervous System (CNS) involvement
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Not specified Cardiovascular: No arrhythmias (except sinus arrhythmia or infrequent premature ventricular contractions) No history of impaired cardiac status (severe coronary artery disease, cardiomyopathy, congestive heart failure, or serious arrhythmia Ejection fraction at least normal Other: HIV negative No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibodies Chemotherapy: No prior chemotherapy for lymphoma Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for lymphoma Surgery: Not specified
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| Name | Affiliation | Role |
|---|---|---|
| Oliver W. Press, MD, PhD | University of Washington | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBCCOP - University of South Alabama | Mobile | Alabama | 36688 | United States | ||
| CCOP - Greater Phoenix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Hsi ED, Rimsza L, Goldman BH, et al.: MUM1 expression in follicular lymphoma is a poor prognostic marker in patients treated with immunochemotherapy (SWOG 9800/9911) but not chemotherapy alone (SWOG 8809): a Southwest Oncology Group correlative science study. [Abstract] Blood 112 (11): A-376, 2008. | ||
| 16230674 | Background | Fisher RI, LeBlanc M, Press OW, Maloney DG, Unger JM, Miller TP. New treatment options have changed the survival of patients with follicular lymphoma. J Clin Oncol. 2005 Nov 20;23(33):8447-52. doi: 10.1200/JCO.2005.03.1674. Epub 2005 Oct 17. | |
| 16896003 |
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| Phoenix |
| Arizona |
| 85006-2726 |
| United States |
| Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix | Arizona | 85012 | United States |
| Veterans Affairs Medical Center - Tucson | Tucson | Arizona | 85723 | United States |
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas | 72205 | United States |
| Beckman Research Institute, City of Hope | Duarte | California | 91010 | United States |
| Veterans Affairs Medical Center - Long Beach | Long Beach | California | 90822 | United States |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033-0800 | United States |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | 94553 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609-3305 | United States |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| UCSF Cancer Center and Cancer Research Institute | San Francisco | California | 94115-0128 | United States |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | 95403 | United States |
| David Grant Medical Center | Travis Air Force Base | California | 94535 | United States |
| Veterans Affairs Medical Center - Denver | Denver | Colorado | 80220 | United States |
| University of Colorado Cancer Center | Denver | Colorado | 80262 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342-1701 | United States |
| Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia | 30905-5650 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois | 60141 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| CCOP - Central Illinois | Springfield | Illinois | 62526 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Veterans Affairs Medical Center - Wichita | Wichita | Kansas | 67218 | United States |
| Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | 40511-1093 | United States |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | 40536-0084 | United States |
| MBCCOP - LSU Medical Center | New Orleans | Louisiana | 70112 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Veterans Affairs Medical Center - New Orleans | New Orleans | Louisiana | 70112 | United States |
| Louisiana State University Hospital - Shreveport | Shreveport | Louisiana | 71130-3932 | United States |
| Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | 71130 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts | 02130 | United States |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | 48105 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0752 | United States |
| Veterans Affairs Medical Center - Detroit | Detroit | Michigan | 48201-1932 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | 49503 | United States |
| Providence Hospital - Southfield | Southfield | Michigan | 48075-9975 | United States |
| Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi | 39531-2410 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | 39216 | United States |
| Keesler Medical Center - Keesler AFB | Keesler Air Force Base | Mississippi | 39534-2576 | United States |
| Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | 64128 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65807 | United States |
| St. Louis University Health Sciences Center | St Louis | Missouri | 63110-0250 | United States |
| CCOP - St. Louis-Cape Girardeau | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | 87108-5138 | United States |
| University of New Mexico Cancer Research & Treatment Center | Albuquerque | New Mexico | 87131 | United States |
| Veterans Affairs Medical Center - Brooklyn | Brooklyn | New York | 11209 | United States |
| Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | 45219 | United States |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | 45220-2288 | United States |
| Cleveland Clinic Cancer Center | Cleveland | Ohio | 44195 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Kettering | Ohio | 45429 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Cancer Center at Oregon Health Sciences University | Portland | Oregon | 97201-3098 | United States |
| Veterans Affairs Medical Center - Portland | Portland | Oregon | 97207 | United States |
| CCOP - Columbia River Program | Portland | Oregon | 97213 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-1329 | United States |
| Texas Tech University Health Science Center | Lubbock | Texas | 79423 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78284 | United States |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | 78284 | United States |
| Veterans Affairs Medical Center - Temple | Temple | Texas | 76504 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84132 | United States |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | 84148 | United States |
| CCOP - Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Veterans Affairs Medical Center - Seattle | Seattle | Washington | 98108 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| Result |
| Press OW, Unger JM, Braziel RM, Maloney DG, Miller TP, Leblanc M, Fisher RI; Southwest Oncology Group. Phase II trial of CHOP chemotherapy followed by tositumomab/iodine I-131 tositumomab for previously untreated follicular non-Hodgkin's lymphoma: five-year follow-up of Southwest Oncology Group Protocol S9911. J Clin Oncol. 2006 Sep 1;24(25):4143-9. doi: 10.1200/JCO.2006.05.8198. Epub 2006 Aug 8. |
| Result | Press OW, Unger J, Maloney D, et al.: An update of a phase II trial of CHOP followed by tositumomab/iodine I-131 tositumomab (Bexxar®) for front-line treatment of advanced stage, follicular lymphoma: Southwest Oncology Group Protocol 9911. [Abstract] Blood 106 (11): A-352, 2005. |
| 12738671 | Result | Press OW, Unger JM, Braziel RM, Maloney DG, Miller TP, LeBlanc M, Gaynor ER, Rivkin SE, Fisher RI. A phase 2 trial of CHOP chemotherapy followed by tositumomab/iodine I 131 tositumomab for previously untreated follicular non-Hodgkin lymphoma: Southwest Oncology Group Protocol S9911. Blood. 2003 Sep 1;102(5):1606-12. doi: 10.1182/blood-2003-01-0287. Epub 2003 May 8. |
| Result | Press OW, Unger JM, Braziel RM, et al.: A phase II trial of CHOP followed by Bexxarâ„¢ (tositumomab and iodine-131-tositumomab) for treatment of newly diagnosed follicular non-Hodgkin's lymphomas (SWOG 9911). [Abstract] Blood 98 (11 Pt 1): A-3504, 2001. |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008258 | Waldenstrom Macroglobulinemia |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| C036337 | VAP-cyclo protocol |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| D014750 | Vincristine |
| C119496 | tositumomab I-131 |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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