Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy

PHASE2TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

June 30, 2011

Study Completion Date

July 31, 2013

Conditions
Lymphoma, Non-Hodgkin
Interventions
DRUG

Bexxar (tositumomab)

Tositumomab is a CD20-directed radiotherapeutic (131-iodine) monoclonal antibody indicated for the treatment of patients with CD20-positive, relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin's lymphoma who have progressed during or after rituximab therapy, including patients with rituximab-refractory non-Hodgkin's lymphoma. Tositumomab (standard regimen) will be administered at whole body exposure of 75 cGy.

PROCEDURE

External beam radiotherapy (XRT)

Patient-specific XRT will begin within 24 hours of administration of the therapeutic dose of tositumomab. Subjects will receive local XRT to bulky sites of disease measuring at least 5 cm in at least one dimension. The size and number of fields to be treated will determined by the investigators, but will encompass the patient's most symptomatic/threatening site(s) of disease and not cumulatively include more than 25% of the active bone marrow. Subjects will be treated with the 2 x 2 Gy regimen (2 daily fractions of 2 Gy). Sites of disease previously-irradiated with 30 to 40 Gy will not be treated on this study.

DRUG

Potassium Iodide (KI)

"Potassium iodide (KI) will be administered as:~* Saturated solution potassium iodide (SSKI) 4 drops orally 3-times-a-day,~* Lugol's solution 20 drops orally 3-times-a-day, OR~* KI tablets 130 mg orally once per day KI treatment will start at least 24 hours prior to tositumomab, and continue daily for 14 days following the last dose of tositumomab"

Trial Locations (1)

94305

Stanford University School of Medicine, Stanford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Stanford University

OTHER

NCT00490490 - Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy | Biotech Hunter | Biotech Hunter