The purpose of this to evaluate in a phase I/II study the efficacy and toxicity of a multi-dose administration of 131I labeled CD22 monoclonal antibody (131I-MAb-LL2) in escalating dose cohorts administered to relapsed non-Hodgkin's lymphoma (NHL) patients. Twenty-one patients with relapsed NHL received one of four dose levels of 131-MAb-LL2 administered in a twice weekly pattern. Starting with dose level 2, the patients also received 20 mg of unlabeled LL2 prior to each radiolabeled dose administered. Previously stored autologous peripheral blood progenitors were reinfused in case of prolonged cytopenias. Patients could repeat the same treatment if they had stable disease or a response to the first therapy at 8 weeks, and had not received their peripheral blood progenitors with the first cycle. Combining all of the dose cohorts, there were 5 complete responses or complete responses (undetermined) and 2 partial responses for a total response rate of 7/21 (33%). There was no dose response effect with responses documented at all dose levels. Expected toxicities were hematopoietic, requiring stem cell re-infusion in 5 patients. Other toxicities included hypothyroidism in 3 patients, and human anti-mouse antibody formation (HAMA) in 4 patients. In conclusion, 131I-MAb-LL2, when administered in a multi-dose fashion with 20 mg unlabeled antibody pre-dosing, resulted in a response rate of 33% in heavily pre-treated NHL patients. Non-hematologic toxicities were mild and few in number. Further evaluation of this treatment is warranted and further dose escalation will be possible.
Objective. To implement and assess a medication therapy management (MTM) training program for pharmacy students using the MirixaPro (Mirixa Corporation, Reston, VA) platform and case studies. Design. Students received lectures introducing MTM and were given a demonstration of the MirixaPro platform. They were divided into teams and assigned cases and times to interview patients portrayed by faculty members. Using the MirixaPro system, students performed 2 comprehensive medication reviews during the semester, recording the patient's current medications, indications, side effects, allergies, health conditions, and laboratory test recommendations and developed a personal medication record and medication action plan. Assessment. Based on a rubric with a rating scale of 0-10, campus and distance pathway students received mean scores ranging from 6.3-7.4 for their performance on the second MTM exercise, an increase of 47%-54% over the first MTM exercise. In qualitative assessments, the majority of students believed that their confidence in providing MTM was enhanced by the activity, while faculty members recognized the advantage of using MirixaPro, which allowed students to experience what is required in processing a pharmacist led, billable MTM encounter. Conclusions. Use of the MirixaPro system and patient cases provides students with a ''hands-on'' experience that may encourage them to promote MTM during their APPEs and provide MTM services as practicing pharmacists.
Radioimmunotherapy with radiolabeled anti-CD20 antibodies is a promising new treatment approach for low-grade non-Hodgkin's lymphoma. However, the administration of radiolabeled antibodies presents some added complexity. At the University of Nebraska Medical Center (Omaha, NE), an institutional model has been developed that ensures the efficient and safe delivery of tositumomab and iodine I 131 tositumomab (Bexxar; Corixa Corp, South San Francisco, CA and GlaxoSmithKline, Philadelphia, PA). An integrated, multidisciplinary treatment team is responsible for managing all aspects of treatment. Using this model, it is possible to administer tositumomab and iodine I 131 tositumomab safely and effectively in the outpatient setting. Patients can usually be released immediately after treatment. Guidelines and instructions for patient release have been developed and validated and are provided herein. These instructions ensure that radiation exposure of family members and caregivers who are exposed to the patient is maintained as low as reasonably achievable and well within regulatory limits.
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