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| Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003849 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 32 |
| Study Start Date: | July 1999 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Arizona | |
| CCOP - Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Siouxland Hematology-Oncology | |
| Sioux City, Iowa, United States, 51101-1733 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Michigan | |
| CCOP - Ann Arbor Regional | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| CentraCare Clinic | |
| Saint Cloud, Minnesota, United States, 56303 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68131 | |
| United States, North Dakota | |
| Altru Health Systems | |
| Grand Forks, North Dakota, United States, 58201 | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Quain & Ramstad Clinic, P.C. | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| CCOP - Toledo Community Hospital Oncology Program | |
| Toledo, Ohio, United States, 43623-3456 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57105-1080 | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| Canada, Saskatchewan | |
| Saskatchewan Cancer Agency | |
| Regina, Saskatchewan, Canada, S4S 6X3 | |
| Study Chair: | Thomas E. Witzig, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000067010, NCCTG-987851 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003849 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult Hodgkin lymphoma stage III grade 1 follicular lymphoma stage IV grade 1 follicular lymphoma |
|
Immunoproliferative Disorders Immunologic Factors Hodgkin Lymphoma, Adult Rituximab Lymphoma, Follicular Hodgkin's Disease Follicular Lymphoma Recurrence |
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Hodgkin Disease |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Hodgkin Disease Lymphoma |
