Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. Giving yttrium Y 90 ibritumomab tiuxetan together with rituximab may be an effective treatment for marginal zone lymphoma.
PURPOSE: This phase II trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with previously untreated marginal zone lymphoma.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma|
- Clinical response rate (complete response [CR], unconfirmed CR, and partial response) [ Time Frame: 6 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Experimental: Zevalin + Rituximab||
IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³Drug: Ibritumomab Tiuxetan
IV injection of In-111 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Other Name: Zevalin
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453102
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com|
|Study Chair:||Izidore S. Lossos, MD||University of Miami|