Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
NCT Number: NCT00416312
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.
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Notify Me18 year–100 year
All sexes
Observational
Baltimore, Maryland, 21231-2410, United States
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to planned radioimmunotherapy treatment (iodine I 131 tositumomab vs yttrium Y 90 ibritumomab tiuxetan).
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Tumor absorbed dose calculation using patient-specific 3D-RD dosimetry software.
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.
Doses calculated using conventional dosimetry software.
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.
Time frame: up to 4 years
tumor absorbed dose (Gy)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Dose-Response in Radioimmunotherapy of Lymphoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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