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Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Waldenstrom's Macroglobulinemia
This study has been completed.
First Received: May 6, 2003   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: NCT00060294
  Purpose

RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 ibritumomab tiuxetan in treating patients who have Waldenstrom's macroglobulinemia.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Radiation: yttrium Y 90 ibritumomab tiuxetan
Phase I

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Rituximab Ibritumomab tiuxetan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma)

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

Study Start Date: March 2003
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan in patients with Waldenstrom's macroglobulinemia.
  • Determine, preliminarily, the response of patients treated with this drug.

OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8).

Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 1. Patients then undergo gamma camera scans within 2-24 hours. Approximately 7-14 days after IDEC-In2B8, patients receive rituximab IV and IDEC-Y2B8 IV over 10 minutes. Treatment with IDEC-Y2B8 may repeat every 12 weeks in the absence of unacceptable toxicity or the achievement of a maximum cumulative dose.

Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 4 years.

PROJECTED ACCRUAL: A total of 3-24 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:

  • Diagnosis of Waldenstrom's macroglobulinemia confirmed by IgM gammopathy and bone marrow biopsy

    • Presence of lymphoplasmacytic cells
    • CD20+ plasma cell dyscrasia on the majority of malignant cells
    • Bone marrow involvement of 20-50% by core needle biopsy of at least 1.5 cm in length
  • Clinical indication for initiation of treatment, including 1 or more of the following characteristics:

    • Symptoms associated with the disease (e.g., fatigue, asthenia, or painful adenopathy)
    • Anemia
    • IgM greater than 3 g/L
    • Progression as indicated by a rate of IgM rise of more than 0.5 g over 6 months
  • No myelodysplastic syndromes or profound hypocellularity of the bone marrow

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • WHO 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count greater than 1,500/mm^3
  • Total B-lymphocyte count less than 5,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • No hyperviscosity syndrome

Hepatic

  • Bilirubin no greater than 1.5 mg/dL

Renal

  • Not specified

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 year after study completion
  • No uncontrolled CNS disease
  • No serious nonmalignant disease that would preclude study participation
  • No other concurrent active malignancy except controlled skin cancer or prostate cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • More than 4 months since prior rituximab
  • No prior radioimmunotherapy

Chemotherapy

  • No prior high-dose chemotherapy (unless patient has had prior back-up stem cell collections)
  • More than 6 weeks since prior chemotherapy

Endocrine therapy

  • More than 4 weeks since prior corticosteroids

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060294

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000301591, UCLA-0202063, IDEC-UCLA-0202063
Study First Received: May 6, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00060294     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
Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Waldenstrom Macroglobulinemia
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphoma
Immunoglobulins
Neoplasms, Plasma Cell

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

ClinicalTrials.gov processed this record on May 06, 2009