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

Primary Purpose

Lymphoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rituximab
yttrium Y 90 ibritumomab tiuxetan
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Waldenström macroglobulinemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2003
Last Updated
January 7, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00060294
Brief Title
Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Waldenstrom's Macroglobulinemia
Official Title
Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
no accrual
Study Start Date
April 2003 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Waldenström macroglobulinemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 ibritumomab tiuxetan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christos E. Emmanouilides, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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

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