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NCT00004040 Clinical Trial

Monoclonal Antibody Therapy or Biological Therapy in Treating Patients With Chronic Lymphocytic Leukemia or Multiple Myeloma in Remission After Chemotherapy

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00004040
Other study ID # CDR0000066763
Secondary ID CBRG-9806NCI-V98
Status Withdrawn
Phase Phase 2
First received December 10, 1999
Last updated August 17, 2015
Start date June 1998
Est. completion date June 1999

Study information
Verified date August 2015
Source Hoag Memorial Hospital Presbyterian
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 1999
Est. primary completion date June 1999
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• recombinant interferon alfa

• rituximab

Locations
Country Name City State
United States St. Joseph Regional Cancer Center Bryan Texas
United States Baptist Regional Cancer Center - Knoxville Knoxville Tennessee
United States Hoag Memorial Hospital Presbyterian Newport Beach California

Sponsors (2)
Lead Sponsor Collaborator
Hoag Memorial Hospital Presbyterian Cancer Biotherapy Research Group

Country where clinical trial is conducted

United States, 

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