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Home > "R" Clinical Trials Conditions > Rituximab in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease  Rituximab in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
Rituximab in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
For Condition: stage 3 grade I follicular small cleaved cell lymphoma,recurrent adult Hodgkin's disease,stage 4 grade I follicular small cleaved cell lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --Prior/Concurrent Therapy-- - See Disease Characteristics --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasWitzig, Study Chair, North Central Cancer Treatment Group
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
Quain & Ramstad Clinic, P.C.
Bismark, North Dakota, 58501
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Saskatchewan Cancer Agency
Regina, Saskatchewan, S4S 6X3
Canada
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Additional Information:
Study ID Numbers: CDR0000067010; NCCTG-987851
Study Start Date: December 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003849
Other Stage 4 Grade I Follicular Small Cleaved Cell Lymphoma Studies:
1. Rituximab in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
2. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma
3. Interferon alfa-2b in Treating Patients With Advanced Low-Grade Non-Hodgkin's Lymphoma
4. Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
5. Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma
Related Studies:
Other stage 4 grade I follicular small cleaved cell lymphoma Clinical Trials
Other North Dakota Clinical Trials
Other Grand Forks Clinical Trials
Rituximab in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
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