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 |
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.
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.
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
We found this trial at
21
sites
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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