Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma
OBJECTIVES:
Primary
- Assess the clinical response rate (complete response [CR], unconfirmed CR, and partial
response) in patients with previously untreated marginal zone lymphoma treated with
yttrium Y 90 ibritumomab tiuxetan and rituximab.
Secondary
- Determine progression-free survival, in terms of time to relapse or progression, of
patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Assess local disease control in these patients
- Evaluate the safety and tolerability of this regimen in these patients.
OUTLINE: Patients receive rituximab IV and indium In 111 ibritumab tiuxetan IV over 10
minutes on day 1. Patients with acceptable biodistribution receive rituximab IV and yttrium
Y 90 ibritumomab tiuxetan IV on day 7, 8, or 9.
After the completion of study treatment, patients are followed every 3 months for 2 years
and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed marginal zone lymphoma (MZL)
- Extranodal, splenic, or nodal MZL
- All stages allowed
- Meets 1 of the following criteria:
- Previously untreated nongastric MZL
- Gastric MZL that did not respond to antibiotic therapy given 2-6 months ago
- Measurable or evaluable disease
- Must not have ≥ 25% bone marrow involvement by MZL
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 6 months
- Platelet count ≥ 100,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- No known HIV positivity
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment
- No physical or mental condition that precludes study compliance
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior or concurrent chemotherapy
- No prior radiotherapy, immunotherapy, systemic corticosteroids, or systemic biologic
anticancer therapy
- No concurrent corticosteroids
- No other concurrent systemic antineoplastic therapy
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical response rate (complete response [CR], unconfirmed CR, and partial response)
Outcome Time Frame:
6 years
Safety Issue:
No
Principal Investigator
Izidore S. Lossos, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Miami Sylvester Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
EPROST-20060078
NCT ID:
NCT00453102
Start Date:
February 2006
Completion Date:
Related Keywords:
- Lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- stage III marginal zone lymphoma
- stage IV marginal zone lymphoma
- contiguous stage II marginal zone lymphoma
- noncontiguous stage II marginal zone lymphoma
- stage I marginal zone lymphoma
- Lymphoma
- Lymphoma, B-Cell, Marginal Zone
Name | Location |
|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
