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Rituximab and Dexamethasone in Treating Patients With Recurrent or Refractory Indolent Non-Hodgkin's Lymphoma

This study has been withdrawn prior to enrollment.
(no patient accrual)
Cancer Biotherapy Research Group
Information provided by:
Hoag Memorial Hospital Presbyterian Identifier:
First received: November 1, 1999
Last updated: August 17, 2015
Last verified: August 2015

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

Resource links provided by NLM:

Further study details as provided by Hoag Memorial Hospital Presbyterian:

Enrollment: 0
Study Start Date: June 1998
Study Completion Date: January 2000
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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Please refer to this study by its identifier: NCT00003663

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
Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian
Cancer Biotherapy Research Group
Study Chair: Robert O. Dillman, MD, FACP Cancer Biotherapy Research Group
  More Information

Responsible Party: Robert O. Dillman, MD, Hoag Memorial Hospital Presbyterian Identifier: NCT00003663     History of Changes
Other Study ID Numbers: CDR0000066756
Study First Received: November 1, 1999
Last Updated: August 17, 2015

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:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antirheumatic Agents processed this record on June 23, 2017