Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Waldenstrom's Macroglobulinemia
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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 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma) |
| Study Start Date: | April 2003 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
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 |
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| 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 | |
| Principal Investigator: | Christos E. Emmanouilides, MD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00060294 History of Changes |
| Other Study ID Numbers: | CDR0000301591, UCLA-0202063, IDEC-UCLA-0202063 |
| Study First Received: | May 6, 2003 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
Waldenström macroglobulinemia |
Additional relevant MeSH terms:
|
Lymphoma Waldenstrom Macroglobulinemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Rituximab Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013