Combined Modality Radioimmunotherapy For Non-Hodgkin's Lymphoma With Three Cycles Of 90Y-DOTA-Peptide-Lym-1, Paclitaxel and Cyclosporin A
- Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody Lym-1 in
combination with paclitaxel and cyclosporine in patients with recurrent or refractory
OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody Lym-1 (Y90 MOAB
Patients receive oral cyclosporine every 12 hours on days -2 to 14. Patients receive
unlabeled MOAB Lym-1 IV followed by a tracer dose of indium In 111 MOAB Lym-1 IV on day 0.
On day 7, patients receive unlabeled MOAB Lym-1 IV followed by Y90 MOAB Lym-1 IV. Patients
in cohorts 2-4 also receive paclitaxel IV over 3 hours on day 9. Courses repeat every 8
weeks for a total of 3 courses in the absence of disease progression or unacceptable
Cohorts of 3 patients receive escalating doses of Y90 MOAB Lym-1 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3
patients experience dose-limiting toxicity.
Patients are followed monthly for 3 months, every 3 months for 21 months, and then every 6
months for 3 years.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 36 months.
Primary Purpose: Treatment
Gerald L. DeNardo, MD
University of California, Davis
United States: Federal Government
|University of California Davis Cancer Center||Sacramento, California 95817|