Doxorubicin-loaded erythrocytes in therapy of patients with lymphoproliferative disorders.

Within the protocol of the first step of the clinical trial of doxorubicin- loaded erythrocytes, we studied their tolerance and pharmacokinetics in thr ee patients with lymphoproliferative disorders. Homologous or autologous er ythrocytes were loaded with doxorubicin aseptically by their incubation at 37 degrees C in a solution of doxorubicin for 1 hour. Immediately after inf usion of doxorubicin in solution (25-50 mg per square meter of body surface area), its concentration in blood rose to 3.60-5.90 mu g/ml. Doxorubicin d eclined 30-fold 20-30 min postinjection and fell to zero 12-24 hours later. When these patients received the same doses of doxorubicin loaded into ery throcytes, doxorubicin in blood ranged from 1.44 to 2.50 mu g/ml immediatel y after infusion. It also sharply decreased within 10-30 min after the inje ction. Thereafter, doxorubicin remained, however, at a level of 0.10 mu g/m l throughout the observation period of three days. Administration of doxoru bicin-loaded erythrocytes produced no adverse effects.