Monoclonal Antibody Therapy or Biological Therapy in Treating Patients With Chronic Lymphocytic Leukemia or Multiple Myeloma in Remission After Chemotherapy
| Status: | Withdrawn |
|---|---|
| Conditions: | Blood Cancer, Hematology, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | June 1998 |
| End Date: | June 1999 |
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.
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.
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.
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.
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
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