Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy With Monoclonal Antibody Therapy in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI SWOG-S0016 CALGB-50102, S0016, NCT00006721, ECOG-SWOG-S0016

Special Category: CTSU trial

Objectives

1. Compare the progression-free survival and overall survival of patients with newly diagnosed follicular non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with or without either rituximab or iodine I 131 tositumomab (monoclonal antibody anti-B1). (CHOP chemotherapy alone arm closed to accrual as of 12/15/02)
2. Compare the response rate of these patients treated with these regimens.
3. Compare the toxic effects of these regimens in these patients.
4. Compare the molecular remission rates of this patient population treated with these regimens.
5. Determine the incidence and time to development of human anti-mouse antibody positivity.

Entry Criteria

Disease Characteristics:

• Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma
  • Grade I-III disease



• CD20 antigen positive



• Fewer than 5,000/mm³ circulating lymphoid cells on a WBC differential count



• Bidimensionally measurable disease



• Bone marrow aspiration and biopsy within the past 42 days



• No clinical evidence of CNS involvement by lymphoma

Prior/Concurrent Therapy:

Biologic therapy:

• No prior monoclonal antibodies for cancer

Chemotherapy:

• No prior chemotherapy for lymphoma
  • Prior prednisone for non-lymphoma related illnesses allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for lymphoma

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics
• Granulocyte count greater than 1,500/mm³
• Platelet count greater than 100,000/mm³

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No impaired cardiac status, including:
  • Severe coronary artery disease
  • Cardiomyopathy
  • Congestive heart failure
  • Serious arrhythmia
• Ejection fraction at least lower limit of normal by MUGA or 2-D echocardiogram for questionable cardiac history

Other:

• No hypersensitivity to iodine
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 6 months after study participation
• HIV negative
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

Expected Enrollment

Approximately 500 patients (250 per treatment arm) will be accrued for this study within 5.5 years. (Arm I closed to accrual as of 12/15/02)

Outcomes

Compare progression-free survival rates of patients treated with CHOP chemotherapy alone, CHOP with rituximab, or CHOP followed by iodine-131 anti-CD20 antibody by Kaplan Meier survival curves at 2 or 5 years

Compare response rates (confirmed and unconfirmed complete and partial responses) by Cheson criteria at 4 weeks and 6 months after completion of therapy and then annually
Compare toxicities by NCI CTC at 4 weeks and 6 months after completion of therapy and then annually

Outline

This is a randomized, multicenter study. Patients are stratified according to whether microglobulin is greater than upper limit of normal (yes vs no). Patients are randomized to 1 of 3 treatment arms. (Arm I closed to accrual as of 12/15/02)

• Arm I (CHOP only): Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)



• Arm II (CHOP + rituximab): Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141.



• Arm III (CHOP + tositumomab): Patients receive chemotherapy as in arm I and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141.

Patients are followed on day 200, at 1 year, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Oliver Press, MD, PhD, Protocol chair		Ph: 206-667-1872 Email: press@u.washington.edu

Cancer and Leukemia Group B

Myron Czuczman, MD, Protocol chair		Ph: 716-845-3221; 800-685-6825 Email: Myron.Czuczman@roswellpark.org

Eastern Cooperative Oncology Group

Sandra Horning, MD, Protocol chair		Ph: 650-725-6456; 800-756-9000

U.S.A.
Alaska
	Anchorage
	Alaska Regional Hospital Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2929
	Fairbanks
	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
		Jacqueline Vuky	Ph:  907-458-5380 800-678-5458
Arkansas
	Ft. Smith
	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
		John Wells, MD	Ph:  479-484-4700 800-333-1305
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Ph:  501-686-8274
California
	Berkeley
	Alta Bates Summit Comprehensive Cancer Center
		Clinical Trials Office - Alta Bates Summit Comprehensive Cancer Center	Ph:  510-204-3428
	Burlingame
	Peninsula Medical Center
		David Irwin, MD	Ph:  510-204-2866
	Greenbrae
	Marin Cancer Institute at Marin General Hospital
		David Irwin, MD	Ph:  510-204-2866
	Sutter Health - Western Division Cancer Research Group
		David Irwin, MD	Ph:  510-204-2866
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
	San Francisco
	California Pacific Medical Center - California Campus
		David Irwin, MD	Ph:  510-204-2866
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph:  650-498-7061
			Email: cctoffice@stanford.edu
	Vallejo
	Sutter Solano Medical Center
		David Irwin, MD	Ph:  510-204-2866
Connecticut
	Hartford
	Helen and Harry Gray Cancer Center at Hartford Hospital
		Clinical Trials Office - Helen and Harry Gray Cancer Center	Ph:  860-545-5363
District of Columbia
	Washington
	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
		Clinical Trials Office - Lombardi Comprehensive Cancer Center	Ph:  202-444-0381
Florida
	Lakeland
	Center for Cancer Care and Research at Watson Clinic, LLP
		Clinical Trials Office - Center for Cancer Care and Research	Ph:  863-680-7780
	Pensacola
	Sacred Heart Cancer Center at Sacred Heart Hospital
		Clinical Trials Office - Sacred Heart Cancer Center	Ph:  850-416-4611
	West Florida Cancer Institute at West Florida Hospital - Pensacola
		Ranjith Dissanayake	Ph:  850-474-8382
Georgia
	Atlanta
	CCOP - Atlanta Regional
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Northside Hospital Cancer Center
		Clinical Trials Office - Northside Hospital Cancer Center	Ph:  404-303-3355
	Piedmont Hospital
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Saint Joseph's Hospital of Atlanta
		Clinical Trials Office - Saint Joseph's Hospital of Atlanta	Ph:  404-851-7115
	Austell
	WellStar Cobb Hospital
		Clinical Trials Office - WellStar Cobb Hospital	Ph:  770-793-5980
	Decatur
	Charles B. Eberhart Cancer Center at DeKalb Medical Center
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Fort Gordon
	Dwight David Eisenhower Army Medical Center
		Mary Edgecomb, DO	Ph:  706-787-2100
	Gainesville
	Northeast Georgia Medical Center
		Charles Nash, MD	Ph:  770-535-3553
	Lawrenceville
	Gwinnett Medical Center
		Thomas Seay, MD, PhD	Ph:  404-851-2340
	Marietta
	Kennestone Cancer Center at Wellstar Kennestone Hospital
		Clinical Trials Office - Kennestone Cancer Center	Ph:  770-793-5980
	Riverdale
	Southern Regional Medical Center
		Clinical Trials Office - Southern Regional Medical Center	Ph:  770-991-8611
	Valdosta
	Pearlman Comprehensive Cancer Center at South Georgia Medical Center
		Jeffrey Hoy, MD	Ph:  229-259-4616
Hawaii
	Honolulu
	Tripler Army Medical Center
		Jeffrey Berenberg, MD	Ph:  808-433-4089
Idaho
	Boise
	Mountain States Tumor Institute at St. Luke's Regional Medical Center
		Theodore Walters, MD	Ph:  208-381-2711 800-845-4624
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Clinical Trials Office - Saint Alphonsus Cancer Care Center	Ph:  208-367-7954
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Aurora
	Rush-Copley Cancer Care Center
		Kendrith Rowland, MD	Ph:  217-383-3010
	Bloomington
	St. Joseph Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3000
	Carthage
	Memorial Hospital
		John Kugler, MD	Ph:  309-243-3000
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
	Decatur
	Decatur Memorial Hospital Cancer Care Institute
		Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute	Ph:  217-876-6601
	Eureka
	Eureka Community Hospital
		John Kugler, MD	Ph:  309-243-3000
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3000
	Galesburg Cottage Hospital
		John Kugler, MD	Ph:  309-243-3000
	Havana
	Mason District Hospital
		John Kugler, MD	Ph:  309-243-3000
	Hines
	Veterans Affairs Medical Center - Hines
		Nirmala Bhoopalam, MD	Ph:  708-202-8387 ext. 22782
	Hopedale
	Hopedale Medical Complex
		John Kugler, MD	Ph:  309-243-3000
	Joliet
	Joliet Oncology-Hematology Associates, Limited - West
		Kendrith Rowland, MD	Ph:  217-383-3010
	Macomb
	McDonough District Hospital
		John Kugler, MD	Ph:  309-243-3000
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
	Mt. Vernon
	Good Samaritan Regional Health Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Naperville
	Edward Hospital Cancer Center
		Clinical Trials Office - Edward Hospital Cancer Center	Ph:  630-646-6075
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3000
	Ottawa
	Community Hospital of Ottawa
		John Kugler, MD	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		John Kugler, MD	Ph:  309-243-3000
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3000
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3000
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		John Kugler, MD	Ph:  309-243-3000
	OSF St. Francis Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Proctor Hospital
		John Kugler, MD	Ph:  309-243-3000
	Peru
	Illinois Valley Community Hospital
		John Kugler, MD	Ph:  309-243-3000
	Princeton
	Perry Memorial Hospital
		John Kugler, MD	Ph:  309-243-3000
	Spring Valley
	St. Margaret's Hospital
		John Kugler, MD	Ph:  309-243-3000
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
	Urbana
	Carle Cancer Center at Carle Foundation Hospital
		Clinical Trials Office - Carle Cancer Center	Ph:  800-446-5532
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  317-787-3311
	Elkhart
	Elkhart General Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Kokomo
	Howard Community Hospital
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Michigan City
	Saint Anthony Memorial Health Centers
		Kendrith Rowland, MD	Ph:  217-383-3010
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  765-983-3000
	South Bend
	CCOP - Northern Indiana CR Consortium
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Saint Joseph Regional Medical Center
		Rafat Ansari, MD, FACP	Ph:  574-234-5123
Iowa
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-9326
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-9326
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-9326
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kansas City
	Providence Medical Center
		Rakesh Gaur, MD