- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003784
S9911, Combination Chemotherapy Plus Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
A Phase II Pilot Trial of CHOP Followed by Iodine-131-Labeled Monoclonal Anti-B1 Antibody for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
-
Mobile, Alabama, United States, 36688
- MBCCOP - University of South Alabama
-
-
Arizona
-
Phoenix, Arizona, United States, 85006-2726
- CCOP - Greater Phoenix
-
Phoenix, Arizona, United States, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
-
Tucson, Arizona, United States, 85724
- Arizona Cancer Center
-
Tucson, Arizona, United States, 85723
- Veterans Affairs Medical Center - Tucson
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
Little Rock, Arkansas, United States, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
-
-
California
-
Duarte, California, United States, 91010
- Beckman Research Institute, City of Hope
-
Long Beach, California, United States, 90822
- Veterans Affairs Medical Center - Long Beach
-
Los Angeles, California, United States, 90033-0800
- USC/Norris Comprehensive Cancer Center
-
Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Martinez, California, United States, 94553
- Veterans Affairs Outpatient Clinic - Martinez
-
Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
-
Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
-
Sacramento, California, United States, 95817
- University of California Davis Medical Center
-
San Francisco, California, United States, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
-
Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
-
Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
-
-
Colorado
-
Denver, Colorado, United States, 80220
- Veterans Affairs Medical Center - Denver
-
Denver, Colorado, United States, 80262
- University of Colorado Cancer Center
-
-
Georgia
-
Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
-
Fort Gordon, Georgia, United States, 30905-5650
- Dwight David Eisenhower Army Medical Center
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- Cancer Research Center of Hawaii
-
-
Illinois
-
Hines, Illinois, United States, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
-
Springfield, Illinois, United States, 62526
- CCOP - Central Illinois
-
-
Kansas
-
Kansas City, Kansas, United States, 66160-7357
- University of Kansas Medical Center
-
Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
-
Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
-
-
Kentucky
-
Lexington, Kentucky, United States, 40511-1093
- Veterans Affairs Medical Center - Lexington
-
Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
-
New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Medical Center
-
New Orleans, Louisiana, United States, 70112
- Veterans Affairs Medical Center - New Orleans
-
Shreveport, Louisiana, United States, 71130
- Veterans Affairs Medical Center - Shreveport
-
Shreveport, Louisiana, United States, 71130-3932
- Louisiana State University Hospital - Shreveport
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
Jamaica Plain, Massachusetts, United States, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109-0752
- University of Michigan Comprehensive Cancer Center
-
Ann Arbor, Michigan, United States, 48105
- Veterans Affairs Medical Center - Ann Arbor
-
Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
Detroit, Michigan, United States, 48201-1932
- Veterans Affairs Medical Center - Detroit
-
Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids Clinical Oncology Program
-
Southfield, Michigan, United States, 48075-9975
- Providence Hospital - Southfield
-
-
Mississippi
-
Biloxi, Mississippi, United States, 39531-2410
- Veterans Affairs Medical Center - Biloxi
-
Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
-
Jackson, Mississippi, United States, 39216
- Veterans Affairs Medical Center - Jackson
-
Keesler AFB, Mississippi, United States, 39534-2576
- Keesler Medical Center - Keesler AFB
-
-
Missouri
-
Kansas City, Missouri, United States, 64128
- Veterans Affairs Medical Center - Kansas City
-
Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
-
Saint Louis, Missouri, United States, 63110-0250
- St. Louis University Health Sciences Center
-
Saint Louis, Missouri, United States, 63141
- CCOP - St. Louis-Cape Girardeau
-
Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
-
-
Montana
-
Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
-
Albuquerque, New Mexico, United States, 87131
- University of New Mexico Cancer Research & Treatment Center
-
-
New York
-
Brooklyn, New York, United States, 11209
- Veterans Affairs Medical Center - Brooklyn
-
New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- Barrett Cancer Center, The University Hospital
-
Cincinnati, Ohio, United States, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Cancer Center
-
Columbus, Ohio, United States, 43206
- CCOP - Columbus
-
Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
-
Kettering, Ohio, United States, 45429
- CCOP - Dayton
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Medical Research Foundation
-
Oklahoma City, Oklahoma, United States, 73104
- Veterans Affairs Medical Center - Oklahoma City
-
-
Oregon
-
Portland, Oregon, United States, 97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
-
Portland, Oregon, United States, 97207
- Veterans Affairs Medical Center - Portland
-
Portland, Oregon, United States, 97213
- CCOP - Columbia River Program
-
-
South Carolina
-
Greenville, South Carolina, United States, 29615
- CCOP - Greenville
-
Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
-
-
Texas
-
Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
-
Galveston, Texas, United States, 77555-1329
- University of Texas Medical Branch
-
Lubbock, Texas, United States, 79423
- Texas Tech University Health Science Center
-
San Antonio, Texas, United States, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
-
San Antonio, Texas, United States, 78284
- University of Texas Health Science Center at San Antonio
-
Temple, Texas, United States, 76504
- Veterans Affairs Medical Center - Temple
-
Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- Huntsman Cancer Institute
-
Salt Lake City, Utah, United States, 84148
- Veterans Affairs Medical Center - Salt Lake City
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, United States, 98101
- CCOP - Virginia Mason Research Center
-
Seattle, Washington, United States, 98104
- Swedish Cancer Institute
-
Seattle, Washington, United States, 98108
- Veterans Affairs Medical Center - Seattle
-
Seattle, Washington, United States, 98195-6043
- University of Washington Medical Center
-
Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Oliver W. Press, MD, PhD, University of Washington
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Press OW, Unger JM, Braziel RM, et al.: A phase II trial of CHOP followed by Bexxar™ (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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV grade 3 follicular lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- Waldenström macroglobulinemia
- noncontiguous stage II grade 3 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Prednisone
- Doxorubicin
- Liposomal doxorubicin
- Tositumomab I-131
- Vincristine
Other Study ID Numbers
- CDR0000066917
- U10CA032102 (U.S. NIH Grant/Contract)
- S9911 (Other Identifier: SWOG)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphoma
-
Marcela V. Maus, M.D.,Ph.D.RecruitingFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Diffuse Large B Cell Lymphoma | Refractory Non-Hodgkin Lymphoma | Primary Mediastinal Large B-cell Lymphoma (PMBCL) | Non-hodgkin Lymphoma | High-grade B-cell Lymphoma | Grade 3b Follicular Lymphoma | Relapsed Non-Hodgkin LymphomaUnited States
-
Novartis PharmaceuticalsBristol-Myers SquibbRecruitingNon-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone LymphomaUnited States, Germany, Italy, Korea, Republic of, Spain, Singapore, China, Japan, Australia
-
Zhejiang UniversityShanghai First Song Therapeutics Co., LtdNot yet recruitingHodgkin Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Diffuse Large B Cell Lymphoma | Gray Zone Lymphoma | NK/T Cell Lymphoma | Peripheral T Cell Lymphoma, Unspecified | Mediastinal B-Cell Diffuse Large Cell LymphomaChina
-
Massachusetts General HospitalTG TherapeuticsActive, not recruitingLymphoma | Follicular Lymphoma | Marginal Zone Lymphoma | Follicular Lymphoma, Grade 1 | Follicular Lymphoma Grade IIIa | Marginal Zone B Cell Lymphoma | Follicular Lymphoma Grade 2United States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedFollicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | Adult Diffuse Large B-Cell Lymphoma | T-Cell Non-Hodgkin LymphomaUnited States
-
IGM Biosciences, Inc.ADC Therapeutics S.A.Active, not recruitingFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | DLBCLUnited States, Korea, Republic of, Spain, France, Australia, Czechia, Italy
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedMantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | Small Lymphocytic Lymphoma | Lymphoproliferative Disorder | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Grade 3 Follicular... and other conditionsUnited States, Canada, Australia, Puerto Rico
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedFollicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | Peripheral T-cell Lymphoma | Diffuse Large B-cell LymphomaUnited States
-
Novartis PharmaceuticalsCompletedDiffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular LymphomaUnited States, Belgium, Germany, France, Italy, Korea, Republic of, Spain, Turkey
-
Ruijin HospitalThe First Affiliated Hospital with Nanjing Medical University; Shanxi Province... and other collaboratorsNot yet recruitingLymphoma | Marginal Zone Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Diffuse Large B Cell Lymphoma | Mucosa-Associated Lymphoid Tissue Lymphoma | Intravascular Large B-Cell Lymphoma | Extranodal Lymphoma | NK/T-Cell Lymphoma, Nasal and Nasal-TypeChina
Clinical Trials on cyclophosphamide
-
Children's Hospital Los AngelesLucile Packard Children's HospitalTerminatedMetabolic Diseases | Stem Cell Transplantation | Chronic Granulomatous Disease | Bone Marrow Transplantation | Thalassemia | Wiskott-Aldrich Syndrome | Genetic Diseases | Peripheral Blood Stem Cell Transplantation | Pediatrics | Diamond-Blackfan Anemia | Allogeneic Transplantation | Combined Immune Deficiency | X-linked Lymphoproliferative Disease
-
Medical College of WisconsinNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsCompletedAnemia, AplasticUnited States
-
Columbia UniversityUnknownSevere Combined Immunodeficiency | Fanconi Anemia | Bone Marrow Failure | OsteopetrosisUnited States
-
National Cancer Institute, NaplesImmatics Biotechnologies GmbH; CureVac; European Commission -FP7-Health-2013-Innovation-1CompletedHepatocellular CarcinomaBelgium, Germany, Italy, Spain, United Kingdom
-
Centre Oscar LambretCompleted
-
Mahidol UniversityTerminatedRenal Insufficiency | InfectionThailand
-
Eisai Inc.CompletedBreast Cancer | Ovarian Cancer | Prostate Cancer | Colon Cancer | Renal CancerUnited States
-
Baylor Research InstituteCompletedMalignant Melanoma Stage IVUnited States
-
University of Turin, ItalyUnknown
-
Merck KGaA, Darmstadt, GermanyCompleted