Trial of Low-Dose Methotrexate and I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

February 28, 2014

Study Completion Date

June 30, 2016

Conditions
Follicular Lymphoma
Interventions
DRUG

Bexxar

"Iodine I 131 tositumomab (Bexxar) is a radioimmunotherapy (RIT) drug. RIT is a treatment strategy designed to target radiation specifically to cancer cells by attaching a radioactive atom to a monoclonal antibody, an immune system protein that binds to a particular protein. The Iodine I 131 tositumomab (Bexxar) therapeutic regimen is delivered in two sets of intravenous infusions given about 7 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body."

DRUG

Low Dose Methotrexate

Methotrexate is an antifolate drug. It interferes with cells' ability to copy their DNA. This mainly affects cells that are dividing frequently, such as immune system cells and cancer cells. Methotrexate will be used in this study to try to prevent the occurrence of HAMA by limiting your body's ability to produce anti mouse antibodies.

Trial Locations (1)

48109

University of Michigan, Ann Arbor

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

University of Michigan Rogel Cancer Center

OTHER

NCT01389076 - Trial of Low-Dose Methotrexate and I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma | Biotech Hunter | Biotech Hunter