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

This study is no longer recruiting patients.

Sponsored by: Cancer Biotherapy Research Group
Information provided by: National Cancer Institute (NCI)

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 after chemotherapy.

Condition Treatment or Intervention Phase
stage II chronic lymphocytic leukemia
stage I multiple myeloma
stage II multiple myeloma
stage IV chronic lymphocytic leukemia
stage III multiple myeloma
stage I chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
B-cell Chronic Lymphocytic Leukemia
Quality of Life
 Drug: interferon alfa
 Drug: rituximab
Phase II

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Rituximab or Interferon Alfa-2b Maintenance Therapy in Patients with Chronic Lymphocytic Leukemia or Multiple Myeloma in Remission After Chemotherapy

Further Study Details: 

Study start: 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.

PROTOCOL 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

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • See Disease Characteristics

--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

Location Information


California
      Hoag Memorial Hospital Presbyterian, Newport Beach,  California,  92658,  United States

Tennessee
      Baptist Regional Cancer Center - Knoxville, Knoxville,  Tennessee,  37901,  United States

Texas
      St. Joseph Regional Cancer Center, Bryan,  Texas,  77802,  United States

Study chairs or principal investigators

Robert O. Dillman,  Study Chair,  Cancer Biotherapy Research Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066763; CBRG-9806; NCI-V98-1495
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004040
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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