Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma)
18 Years
N/A
Both
Lymphoma
Trial Information
Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Christos E. Emmanouilides, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000301591
NCT ID:
NCT00060294
Start Date:
April 2003
Completion Date:
Related Keywords:
- Lymphoma
- Waldenström macroglobulinemia
- Lymphoma
- Waldenstrom Macroglobulinemia
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
