Rituximab and Dexamethasone in Treating Patients With Recurrent or Refractory Indolent Non-Hodgkin's Lymphoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Study Completion Date: | January 2000 |
| Primary Completion Date: | January 2000 (Final data collection date for primary outcome measure) |
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
No publications provided
| Responsible Party: | Robert O. Dillman, MD, Hoag Memorial Hospital Presbyterian |
| ClinicalTrials.gov Identifier: | NCT00003663 History of Changes |
| Other Study ID Numbers: | CDR0000066756, CBRG-9805, NCI-V98-1492 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 10, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Hoag Memorial Hospital Presbyterian:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Rituximab BB 1101 Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013