- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004040
Monoclonal Antibody Therapy or Biological Therapy in Treating Patients With Chronic Lymphocytic Leukemia or Multiple Myeloma in Remission After Chemotherapy
Patients With Chronic Lymphocytic Leukemia or Multiple Myeloma Whose Disease Has Been Controlled With Chemotherapy: Rituximab Anti-CD20 Monoclonal Antibody or Interferon Alpha 2-b as Maintenance Therapy
RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as interferon alfa-2b use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase II trial to study the effectiveness of rituximab or interferon alfa-2b in treating patients who have chronic lymphocytic leukemia or multiple myeloma in remission.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the toxicity of rituximab or interferon alfa-2b maintenance therapy in patients with chronic lymphocytic leukemia or multiple myeloma in remission after chemotherapy. II. Determine the progression free survival, failure free survival, and overall survival of these patients from time of chemotherapy discontinuation to completion of maintenance therapy. III. Compare the survival rates of these patients to similar patients treated in published studies. IV. Determine the quality of life of these patients on these regimens.
OUTLINE: Patients enter one of two treatment arms: Arm I: Patients receive rituximab IV on days 1, 8, 15, and 22 for course 1, and then once a month for 11 months or until disease progression. Arm II: Patients receive subcutaneous interferon alfa-2b every other day three times per week for 12 months. Quality of life is assessed monthly during therapy. Patients are followed every 3 months for 1 year, and then annually for up to 5 years.
PROJECTED ACCRUAL: A total of 60-80 patients (30-40 per disease type) will be accrued for this study.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Newport Beach, California, United States, 92658
- Hoag Memorial Hospital Presbyterian
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Tennessee
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Knoxville, Tennessee, United States, 37901
- Baptist Regional Cancer Center - Knoxville
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Texas
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Bryan, Texas, United States, 77802
- St. Joseph Regional Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: B-cell chronic lymphocytic leukemia or multiple myeloma in remission that was previously treated with chemotherapy without disease progression
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Lymphocyte count less than 10,000/mm3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection or other concurrent lifethreatening disease Medical condition satisfactory for treatment with chemotherapy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Robert O. Dillman, MD, FACP, Cancer Biotherapy Research Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Leukemia, B-Cell
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Plasmacytoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Interferons
- Interferon-alpha
- Rituximab
Other Study ID Numbers
- CDR0000066763
- CBRG-9806
- NCI-V98-1495
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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