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Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004889
  Purpose

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstrom's macroglobulinemia.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Rituximab (Rituxan, Mabthera) in Waldenstrom's Macroglobulinemia

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 1999
Detailed Description:

OBJECTIVES: I. Determine the objective response, time to treatment failure, and toxicity in patients with Waldenstrom's macroglobulinemia treated with rituximab. II. Correlate expression and changes in expression of CD20 on patient plasma cells and B-cells with clinical responses.

OUTLINE: This is a multicenter study. Patients receive rituximab IV weekly for 4 weeks. Treatment may be repeated 2 months later in patients with stable disease, partial response, or complete response. Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 12-25 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Waldenstrom's macroglobulinemia No more than 2 prior courses of therapy No requirement for chemotherapy or steroid therapy for 90 days in previously untreated patients with slowly progressive disease

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 25,000/mm3 Hepatic: Bilirubin less than 2.5 times upper limit of normal (ULN) SGOT less than 2.5 times ULN Renal: Creatinine less than 2.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study No serious concurrent disease No concurrent uncontrolled bacterial, fungal, or viral infection No active second malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 30 days since prior chemotherapy Endocrine therapy: See Disease Characteristics At least 30 days since prior steroid therapy Radiotherapy: At least 30 days since prior radiotherapy Surgery: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004889

Locations
United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067565, UCLA-9909016, NCI-G00-1709
Study First Received: March 7, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004889     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Waldenstrom macroglobulinemia

Study placed in the following topic categories:
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Hemorrhagic Disorders
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Rituximab
Hematologic Diseases
Blood Protein Disorders
Physiological Effects of Drugs
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Pharmacologic Actions
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009