Non Hodgkin Lymphoma Clinical Trial
S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin’s Lymphoma
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.
Full Description
OBJECTIVES:
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)
Compare the response rate of these patients treated with these regimens.
Compare the toxic effects of these regimens in these patients.
Compare the molecular remission rates of this patient population treated with these regimens.
Determine the incidence and time to development of human anti-mouse antibody positivity.
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.
PROJECTED ACCRUAL: 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)
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma
Grade I-III disease
Cluster of differentiation antigen 20 (CD20) antigen positive
Fewer than 5,000/mm^3 circulating lymphoid cells on a white blood cell (WBC) differential count
Bidimensionally measurable disease
Bone marrow aspiration and biopsy within the past 42 days
No clinical evidence of central nervous system (CNS) involvement by lymphoma
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/mm^3
Platelet count greater than 100,000/mm^3
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 Multi Gated Acquisition Scan (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
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 218 Locations for this study
Anchorage Alaska, 99508, United States
Fairbanks Alaska, 99701, United States
Fort Smith Arkansas, 72903, United States
Little Rock Arkansas, 72205, United States
Berkeley California, 94704, United States
Burlingame California, 94010, United States
Greenbrae California, 94904, United States
Greenbrae California, 94904, United States
Palm Springs California, 92262, United States
Sacramento California, 95817, United States
San Francisco California, 94118, United States
Stanford California, 94305, United States
Vallejo California, 94589, United States
Hartford Connecticut, 06102, United States
Washington District of Columbia, 20007, United States
Lakeland Florida, 33805, United States
Pensacola Florida, 32504, United States
Pensacola Florida, 32514, United States
Atlanta Georgia, 30309, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Austell Georgia, 30106, United States
Decatur Georgia, 30033, United States
Fort Gordon Georgia, 30905, United States
Gainesville Georgia, 30501, United States
Lawrenceville Georgia, 30045, United States
Marietta Georgia, 30060, United States
Riverdale Georgia, 30274, United States
Valdosta Georgia, 31603, United States
Honolulu Hawaii, 96859, United States
Boise Idaho, 83706, United States
Boise Idaho, 83712, United States
Alton Illinois, 62002, United States
Aurora Illinois, 60504, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Hines Illinois, 60141, United States
Hopedale Illinois, 61747, United States
Joliet Illinois, 60435, United States
Macomb Illinois, 61455, United States
Maywood Illinois, 60153, United States
Mount Vernon Illinois, 62864, United States
Naperville Illinois, 60540, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Spring Valley Illinois, 61362, United States
Springfield Illinois, 62781, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Beech Grove Indiana, 46107, United States
Elkhart Indiana, 46515, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Michigan City Indiana, 46360, United States
Richmond Indiana, 47374, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Independence Kansas, 67301, United States
Kansas City Kansas, 66112, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Overland Park Kansas, 66209, United States
Overland Park Kansas, 66210, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Salina Kansas, 67401, United States
Shawnee Mission Kansas, 66204, United States
Topeka Kansas, 66606, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21215, United States
Burlington Massachusetts, 01805, United States
Pittsfield Massachusetts, 01201, United States
Ann Arbor Michigan, 48109, United States
Battle Creek Michigan, 49017, United States
Bay City Michigan, 48708, United States
Big Rapids Michigan, 49307, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Holland Michigan, 49423, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Muskegon Michigan, 49442, United States
Saint Joseph Michigan, 49085, United States
Saint Joseph Michigan, 49085, United States
Traverse City Michigan, 49684, United States
Wyoming Michigan, 49519, United States
Jackson Mississippi, 39216, United States
Cape Girardeau Missouri, 63701, United States
Cape Girardeau Missouri, 63703, United States
Chesterfield Missouri, 63017, United States
Columbia Missouri, 65201, United States
Columbia Missouri, 65203, United States
Independence Missouri, 64050, United States
Joplin Missouri, 64804, United States
Joplin Missouri, 64804, United States
Kansas City Missouri, 64108, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64114, United States
Kansas City Missouri, 64114, United States
Kansas City Missouri, 64116, United States
Kansas City Missouri, 64116, United States
Kansas City Missouri, 64131, United States
Kansas City Missouri, 64154, United States
Saint Joseph Missouri, 64506, United States
Saint Louis Missouri, 63109, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65802, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59801, United States
Missoula Montana, 59804, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Kearney Nebraska, 68848, United States
Omaha Nebraska, 68198, United States
Buffalo New York, 14263, United States
Middletown New York, 10940, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27710, United States
Goldsboro North Carolina, 27534, United States
Akron Ohio, 44307, United States
Bellefontaine Ohio, 43311, United States
Chillicothe Ohio, 45601, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Delaware Ohio, 43015, United States
Findlay Ohio, 45840, United States
Franklin Ohio, 45005, United States
Independence Ohio, 44131, United States
Kettering Ohio, 45429, United States
Lancaster Ohio, 43130, United States
Lima Ohio, 45801, United States
Marietta Ohio, 45750, United States
Newark Ohio, 43055, United States
Springfield Ohio, 45504, United States
Springfield Ohio, 45505, United States
Troy Ohio, 45373, United States
Westerville Ohio, 43081, United States
Wilmington Ohio, 45177, United States
Wooster Ohio, 44691, United States
Xenia Ohio, 45385, United States
Zanesville Ohio, 43701, United States
Gresham Oregon, 97030, United States
Milwaukie Oregon, 97222, United States
Portland Oregon, 97210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97216, United States
Portland Oregon, 97225, United States
Portland Oregon, 97225, United States
Portland Oregon, 97227, United States
Tualatin Oregon, 97062, United States
Charleston South Carolina, 29401, United States
Charleston South Carolina, 29425, United States
Columbia South Carolina, 29203, United States
Greenville South Carolina, 29615, United States
Lubbock Texas, 79410, United States
Lubbock Texas, 79415, United States
Salt Lake City Utah, 84112, United States
Lynchburg Virginia, 24501, United States
Bellingham Washington, 98225, United States
Bremerton Washington, 98310, United States
Federal Way Washington, 98003, United States
Kennewick Washington, 99336, United States
Kirkland Washington, 98033, United States
Port Angeles Washington, 98362, United States
Puyallup Washington, 98372, United States
Renton Washington, 98055, United States
Seattle Washington, 98101, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98112, United States
Seattle Washington, 98122, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
Spokane Washington, 99202, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98499, United States
Vancouver Washington, 98668, United States
Wenatchee Washington, 98801, United States
Yakima Washington, 98902, United States
Wheeling West Virginia, 26003, United States
Sheridan Wyoming, 82801, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.