Monoclonal Antibody Therapy, Paclitaxel, and Cyclosporine in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
Recruitment status was Active, not recruiting
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with cyclosporine and paclitaxel may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy combined with paclitaxel and cyclosporine in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.
Biological: monoclonal antibody Lym-1
Radiation: indium In 111 monoclonal antibody Lym-1
Radiation: yttrium Y 90 monoclonal antibody Lym-1
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Combined Modality Radioimmunotherapy For Non-Hodgkin's Lymphoma With Three Cycles Of 90Y-DOTA-Peptide-Lym-1, Paclitaxel and Cyclosporin A|
|Study Start Date:||March 2001|
- 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 non-Hodgkin's lymphoma.
OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody Lym-1 (Y90 MOAB Lym-1).
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 toxicity.
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.
|United States, California|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95816|
|Study Chair:||Gerald L. DeNardo, MD||University of California, Davis|