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| Sponsored by: |
Cancer Biotherapy Research Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004040 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Multiple Myeloma and Plasma Cell Neoplasm |
Biological: recombinant interferon alfa Biological: rituximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | June 1998 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Hoag Memorial Hospital Presbyterian | |
| Newport Beach, California, United States, 92658 | |
| United States, Tennessee | |
| Baptist Regional Cancer Center - Knoxville | |
| Knoxville, Tennessee, United States, 37901 | |
| 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: | CDR0000066763, CBRG-9806, NCI-V98-1495 |
| Study First Received: | December 10, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004040 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma stage I chronic lymphocytic leukemia |
stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia B-cell chronic lymphocytic leukemia |
|
Interferon Type I, Recombinant Leukemia, Lymphoid Immunologic Factors Blood Protein Disorders Paraproteinemias Hemostatic Disorders Antibodies, Monoclonal Leukemia Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Immunoglobulins Interferon-alpha Immunoproliferative Disorders Hematologic Diseases |
Rituximab Blood Coagulation Disorders Interferons Vascular Diseases Angiogenesis Inhibitors Antiviral Agents Multiple Myeloma Lymphatic Diseases Chronic Lymphocytic Leukemia Antibodies Antirheumatic Agents Lymphoproliferative Disorders Leukemia, B-Cell Interferon Alfa-2a Interferon Alfa-2b |
|
Anti-Infective Agents Leukemia, Lymphoid Interferon Type I, Recombinant Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Antibodies, Monoclonal Leukemia Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Cardiovascular Diseases |
Growth Inhibitors Angiogenesis Modulating Agents Interferon-alpha Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Rituximab Growth Substances Interferons Vascular Diseases Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions Multiple Myeloma |
