Randomized phase II study of immunomodulator Z-100 in patients with stage IIIB cervical cancer with radiation therapy

Abstract

Objective: To find the optimal dose of immunomodulator Z-100 in patients with stage IIIB squamous cell carcinoma of the cervix in combination with radiation therapy. Methods: The patients were randomly assigned to the dosage levels of 2, 20 or 40 μg of Z-100. Z-100 was subcutaneously injected twice a week during radiotherapy and once in two weeks during the maintenance period. The response rate after radiotherapy was evaluated, and the optimal clinical dosage was then determined. Safety of Z-100 was evaluated during the radiation therapy and maintenance therapy. Survival was also evaluated. Results: A total of 116 patients were entered. The adverse reactions were not dose-dependent and no serious toxicities were observed. The response rates were 72.2% (26/36) in the 2 μg group, 84.6% (33/39) in the 20 μg group and 94.3% (33/35) in the 40 μg group (P = 0.006). However, the survival was not significantly different. Conclusions: The optimal dose of Z-100 was determined to be 40 μg in combination with radiation therapy for stage IIIB cervical cancer. However, impact of Z-100 on survival must be determined by the placebo controlled randomized trial, because survival benefit was not observed in this small population study. © 2006 Oxford University Press.