Rituximab in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease



Status:Completed
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/14/2016
Start Date:July 1999
End Date:February 2008

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A Phase II Trial of C2B8 in Patients With Asymptomatic CD20+ B-Cell Follicular Small Cleaved Low-Grade Non-Hodgkin's Lymphoma or Relapsed CD20+ Hodgkin's Disease

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver
cancer-killing substances to them.

PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who
have non-Hodgkin's lymphoma or Hodgkin's disease.

OBJECTIVES: I. Determine the response rate (complete or partial) to rituximab in previously
untreated patients with stage III or IV CD20+ B-cell follicular small cleaved cell
non-Hodgkin's lymphoma. II. Determine the response rate (complete or partial) to rituximab
in patients with relapsed CD20+ Hodgkin's disease. III. Determine the time to progression
and time to chemotherapy in these patients after treatment with rituximab.

OUTLINE: Patients are stratified according to disease (follicular small cleaved cell
non-Hodgkin's lymphoma vs relapsed Hodgkin's disease). Patients receive rituximab IV over
4-6 hours on day 1 weekly for 4 weeks. Patients are followed at 1, 3, 6, 9, and 12 months,
then every 6 months for 3 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 21-32 patients will be accrued for each arm of this study
within 7-10.5 months.

DISEASE CHARACTERISTICS: Histologically proven stage IIIA or stage IVA B-cell follicular
small cleaved cell non-Hodgkin's lymphoma Tumor cells express CD20 No prior chemotherapy
or radiotherapy Stable disease that would otherwise be observed OR Histologically proven
relapsed Hodgkin's disease of any stage Tumor cells express CD20 Bidimensionally
measurable disease Masses (e.g., enlarged lymph nodes) must be at least 1.5 cm X 1.5 cm by
CT, MRI, or x-ray Splenic enlargement considered measurable if spleen palpable at least 3
cm below the left costal margin No CNS lymphoma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: No more than 5,000 circulating tumor cells Hepatic: Not
specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use
effective contraception during and for at least 12 months following study HIV negative No
other active malignancies

PRIOR CONCURRENT THERAPY: See Disease Characteristics
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Ann Arbor, Michigan 48106
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Bismarck, North Dakota 58501
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Cedar Rapids, Iowa 52403
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Cedar Rapids, IA
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
(515) 244-7586
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Des Moines, IA
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400 E Third Street
Duluth, Minnesota 55805
(218) 786-3868
CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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Fargo, North Dakota 58122
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Grand Forks, North Dakota 58201
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New Orleans, Louisiana 70121
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Omaha, NE
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Peoria, IL
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Regina, Saskatchewan
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Regina,
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Rochester, MN
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Saint Cloud, Minnesota 56303
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Saint Louis Park, Minnesota 55416
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Scottsdale, Arizona 85259
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Sioux City, Iowa 51101
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Sioux Falls, South Dakota 57104
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509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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Wichita, Kansas 67214
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