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| Sponsored by: |
Cancer Biotherapy Research Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003663 |
Purpose
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining the monoclonal antibody rituximab with dexamethasone may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab and dexamethasone in treating patients with recurrent or refractory indolent non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: dexamethasone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Rituximab Anti-CD20 Monoclonal Antibody and Dexamethasone in the Treatment of Relapsed Indolent Lymphoma |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 1998 |
OBJECTIVES: I. Determine the toxic effects of rituximab and dexamethasone in patients with recurrent or refractory indolent non-Hodgkin's lymphoma. II. Determine the objective tumor response rate and duration of response at 2 months after initiation of therapy, and the percentage of patients with progressive disease. III.
Determine the maximum response, duration of response, and progression free interval for patients who have not progressed after 4 weeks of therapy. IV. Determine the failure-free and overall survival of these patients on this regimen. V. Compare the response rate and survival rates to results for similar patients (historical and concurrent) who have received 4 weeks of rituximab without dexamethasone, and patients who did not receive maintenance rituximab.
OUTLINE: Patients receive dexamethasone IV followed by rituximab IV on days 1, 8, 15, and 22 for one course. Two months after initiating treatment, patients are evaluated for disease progression. Patients with stable or responding disease may receive monthly dexamethasone and rituximab therapy for up to 10 additional months.
Patients are followed every 3 months for 2 years, then every 6 months for years 3-4, and then yearly for up to 5 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven stage III or IV, recurrent or refractory, indolent B cell non-Hodgkin's lymphoma of the following types: Working Group Formulation A (small cell lymphocytic) Working Group Formulation B, C, and D (follicular) Must have relapsed after prior chemotherapy At least 1 lymph node or visceral lesion at least 2 cm in diameter
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Lymphocyte count less than 5,000/mm3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection HIV negative No hepatitis B or C No concurrent life threatening condition
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy for lymphoma (e.g., rituximab) Chemotherapy: See Disease Characteristics Endocrine therapy: No other concurrent corticosteroids and/or epinephrine (unless anaphylactic shock) Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations| United States, California | |
| Hoag Memorial Hospital Presbyterian | |
| Newport Beach, California, United States, 92658 | |
| United States, Indiana | |
| Cancer Care Center for Southern Indiana | |
| Bloomington, Indiana, United States, 47403 | |
| United States, Texas | |
| St. Joseph Regional Cancer Center | |
| Bryan, Texas, United States, 77802 | |
| Study Chair: | Robert O. Dillman, MD, FACP | Cancer Biotherapy Research Group |
More Information
| Study ID Numbers: | CDR0000066756, CBRG-9805, NCI-V98-1492 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003663 History of Changes |
| Health Authority: | United States: Federal Government |
|
Waldenstrom macroglobulinemia stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma stage III small lymphocytic lymphoma stage III marginal zone lymphoma stage IV small lymphocytic lymphoma stage IV marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
|
Anti-Inflammatory Agents Dexamethasone Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoma, Follicular Antiemetics Lymphoma, B-Cell, Marginal Zone Hormones Follicular Lymphoma Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Antibodies, Monoclonal Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic |
Lymphoma Dexamethasone acetate Immunoglobulins Immunoproliferative Disorders Antineoplastic Agents, Hormonal Rituximab Glucocorticoids Recurrence Lymphatic Diseases Waldenstrom Macroglobulinemia Chronic Lymphocytic Leukemia Antibodies B-cell Lymphomas Peripheral Nervous System Agents Antirheumatic Agents |
|
Dexamethasone Anti-Inflammatory Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones 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 Central Nervous System Agents |
