Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Device: Patient-specific dosimetryDevice: conventional dosimetry
- Registration Number
- NCT00416312
- Brief Summary
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab and yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. This may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan works in treating patients with non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
Primary
* Determine the relationship between estimated absorbed dose and tumor response using different dosimetric methodologies in patients with non-Hodgkin's lymphoma treated with iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan.
* Determine the relationship between estimated absorbed dose and normal organ toxicity using different dosimetric methodologies in these patients.
Secondary
* Assess the difference in the dose-response relationship between dosimetric methodologies in these patients.
* Assess the influence of prior therapy on the dose-response relationship for hematologic toxicity in these patients.
OUTLINE: Patients are stratified according to planned radioimmunotherapy treatment (iodine I 131 tositumomab vs yttrium Y 90 ibritumomab tiuxetan).
* Stratum 1: Patients receive dosimetric rituximab IV followed by indium In 111 (\^111In) ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT scans between 2-24, 48-72, and 90-120 hours after \^111In ibritumomab tiuxetan administration. Patients who have acceptable biodistribution receive therapeutic rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between days 7-9.
* Stratum 2: Patients receive dosimetric tositumomab IV over 60 minutes followed by iodine I 131 (\^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT scans and SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable biodistribution receive therapeutic tositumomab IV over 60 minutes followed by \^131I tositumomab IV over 20 minutes on approximately day 7.
In both strata, blood is collected at baseline to measure FLT-3 levels. All patients also undergo a baseline PET/CT scan.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Conventional & Patient-Specific Dosimetry Patient-specific dosimetry Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software. Conventional & Patient-Specific Dosimetry conventional dosimetry Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
- Primary Outcome Measures
Name Time Method Tumor Absorbed Dose up to 4 years tumor absorbed dose (Gy)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States