CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
Patient-specific dosimetry +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00416312
NCT00416312N/ACompleted

Dose-Response in Radioimmunotherapy of Lymphoma

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·observational·Posted Dec 28, 2006·Updated Aug 27, 2018

In Brief

An observational study evaluating Patient-specific dosimetry and conventional dosimetry for Lymphoma. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2006
Enrollment StartJul 1, 2006
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.5 years ago

Interventions

Patient-specific dosimetrydevice

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.

conventional dosimetrydevice

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.