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Sponsored by: |
Puget Sound Oncology Consortium at Fred Hutchinson Cancer Research Center |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00244855 |
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with dexamethasone works in treating patients with B-cell non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Biological: rituximab Drug: dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Evaluating the Efficacy of Rituximab and Dexamethasone in CD20 Positive Low Grade and Follicular Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 96 |
Study Start Date: | January 2005 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is multicenter study.
Patients receive dexamethasone IV over 30 minutes and rituximab IV once weekly for 4 weeks in the absence of unacceptable toxicity. Patients with progressive disease at the 6-month follow-up visit may be retreated on this protocol with dexamethasone and rituximab.
After completion of study treatment, patients are followed at 3 and 6 months and then every 6 months until disease progression.
PROJECTED ACCRUAL: Approximately 40-96 patients (20-52 with previously treated or relapsed disease and 20-44 with previously untreated disease) will be accrued for this study within 2-3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed low-grade B-cell non-Hodgkin's lymphoma, including any of the following subtypes:
The following diagnoses are not allowed:
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109-1023 |
Principal Investigator: | David G. Maloney, MD, PhD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( David G. Maloney ) |
Study ID Numbers: | CDR0000441527, PSOC-2002, GENENTECH-PSOC-2002, PSOC-IRB-5794 |
Study First Received: | October 25, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00244855 History of Changes |
Health Authority: | United States: Federal Government |
contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 1 follicular lymphoma |
stage IV grade 2 follicular lymphoma contiguous stage II marginal zone lymphoma noncontiguous stage II marginal zone lymphoma recurrent marginal zone lymphoma splenic marginal zone lymphoma stage I marginal zone lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue Waldenstrom macroglobulinemia nodal marginal zone B-cell lymphoma |
Dexamethasone Anti-Inflammatory Agents Immunologic Factors Hormone Antagonists Lymphoma, Follicular Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Lymphoma, B-Cell, Marginal Zone Follicular Lymphoma Hormones Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Lymphoma |
Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Rituximab Glucocorticoids Recurrence Lymphatic Diseases Waldenstrom Macroglobulinemia B-cell Lymphomas Peripheral Nervous System Agents Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Anti-Inflammatory Agents Dexamethasone Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Lymphoma, Follicular Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Lymphoma, B-Cell Therapeutic Uses Lymphoma Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Antineoplastic Agents, Hormonal Rituximab Gastrointestinal Agents Glucocorticoids Pharmacologic Actions Lymphatic Diseases Neoplasms Autonomic Agents Peripheral Nervous System Agents Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Central Nervous System Agents |