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Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Waldenstrom's Macroglobulinemia - Article


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Waldenström's Macroglobulinemia



Clinical Trial: Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Waldenstrom's Macroglobulinemia

This study has been completed.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
Waldenstrom's Macroglobulinemia
 Drug: rituximab
 Drug: yttrium Y 90 ibritumomab tiuxetan
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: isotope therapy
 Procedure: monoclonal antibody therapy
 Procedure: radiation therapy
 Procedure: radioimmunotherapy
Phase I

MedlinePlus related topics:  Blood and Blood Disorders;   Immune System and Disorders;   Lymphatic Diseases;   Vascular Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Waldenstrom's Macroglobulinemia

Further Study Details: 

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 above,  Genders Eligible for Study:  Both

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

Endocrine therapy

  • More than 4 weeks since prior corticosteroids

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified

Location Information


California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

Study chairs or principal investigators

Christos E. Emmanouilides, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

More Information

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

Study ID Numbers:  CDR0000301591; UCLA-0202063; IDEC-UCLA-0202063
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00060294
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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November 18, 2008



Page Updated: September 23, 2004
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