Clinical trial NCT00004040: Monoclonal Antibody Therapy or Biological Therapy in Treating Patients With Chronic Lymphocytic Leukemia or Multiple Myeloma in Remission After Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Leukemia
Multiple Myeloma and Plasma Cell Neoplasm
Keywords: 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
Lead sponsor: Hoag Memorial Hospital Presbyterian
Sponsor class: OTHER
Collaborators: name: Cancer Biotherapy Research Group
First posted: 2004-08-05
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Knoxville
country: United States
facility: Baptist Regional Cancer Center - Knoxville
state: Tennessee
city: Bryan
country: United States
facility: St. Joseph Regional Cancer Center
state: Texas
Study officials:
affiliation: Cancer Biotherapy Research Group
name: Robert O. Dillman, MD, FACP
role: STUDY_CHAIR
References: