[Treatment with K-18 (IgG-melphalan) in recurrent cases of hematopoietic malignancies].
K 18, an IgG-Melphalan conjugate was administered to 30 patients, who had recurrent hematopoietic malignancy. Ten out of the 30 patients received single doses of 1 to 20 enteric tablets containing 10 mg of K 18, as a phase I study. No side effects were observed. K 18 was administered every day to the remaining 20 patients in order to evaluate the side effects and therapeutic effects, as a phase II study. One patient attained partial remission. Although no remission effect was obtained in 14 of the 20 patients, antitumor effects such as a decrease in leukemia cells, were observed in 4 of 20 patients. As to side effects, neither recurrence of tumor nor cumulative toxicity were shown in one patient with NHL who received only K 18 for 14 months as maintenance therapy. Evaluation of antitumor effect was difficult in the case of the remaining 4 patients. In the 20 cases who entered the phase II study, a decrease in neutrophils was observed in 2 patients, a slight decrease in platelets in 3 patients and increased transaminase activity in one patient as side effects of K 18. In brief, compared with Melphalan, K 18 has between 1.3 and 2 times a more potent therapeutic effect, with extremely low side effects.
Shibata
H
H
Ueda
T
T
Kanakura
Y
Y
Mitsui
H
H
Nakagawa
M
M
Yakura
H
H
Taoka
T
T
Tejima
H
H
Hiraoka
A
A
Masaoka
T
T
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D007938:Leukemia / Q000628:therapy*; D007945:Leukemia, Lymphoid / Q000628:therapy; D007951:Leukemia, Myeloid / Q000628:therapy; D008297:Male; D008558:Melphalan / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D009101:Multiple Myeloma / Q000628:therapy
D007074:Immunoglobulin G; D008558:Melphalan