Pilot Trial of Radioimmunotherapy With Yttrium 90-Labeled (90Y) Zevalin for Low-Grade Follicular Non-Hodgkin's Lymphoma or MALT of the Orbit/Conjunctiva
Rituximab and Zevalin are monoclonal antibodies that bind to lymphoma cells and cause cell
As is the case for all patients with orbital lymphoma, an orbital biopsy must be performed
to confirm the diagnosis and status of the orbital lymphoma. The study doctors must first
make sure that the disease has not spread too much and is not severe enough to require
immediate treatment with chemotherapy before you can begin treatment on this study. You
will have about 4 teaspoons of blood drawn. Women who are able to have children must have a
negative blood or urine pregnancy test.
You will receive two injections of rituximab by vein over about 4 to 6 hours. This is
followed by an infusion of Zevalin over about 30 minutes on the same day. Whole body images
will be performed immediately and at 4-6, 24, 72, and 144 hours after receiving Zevalin.
About 1 week later, you will receive a second infusion of rituximab and Zevalin.
You may be taken off the study if your orbital lymphoma does not respond within three months
of receiving rituximab and Zevalin. Researchers will measure your response to therapy using
MRI of the orbit and an evaluation of the eye in the clinic. If you are taken off study,
you will be given the option of receiving external beam radiation therapy as treatment for
Follow-up evaluations will be done every 3 months for 2 years and every 6 months for Years
3 and 4. This testing is considered standard of care and would include medical history,
physical exam, blood tests, and urine tests. The status of the disease will be evaluated
using CT scan or MRI of the orbit every 3 months for the first year and every 6 months for
Years 2, 3, and 4. Blood tests (about 4 teaspoons each) will be every 3 months for the
first year and may be continues every 3 to 6 month until they become negative or you start
another anti-cancer therapy.
This is an investigational study. Zevalin and rituximab are both FDA approved but their use
together in this study is investigational. A total of up to 12 patients will take part in
this study. All will be enrolled at M.D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with CR or PR Response
Tumor response to therapy based on clinical parameters and radiographically. At 3 months, tumor response classified as CR (complete response) or PR (partial response), or SD (stable disease), or PD (progressive disease).
Bita Esmaeli, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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