[Phase I, II studies of recombinant granulocyte colony stimulating factor (gamma hG-CSF)]

Results obtained in phase I-II studies of gamma hG-CSF were reviewed. An optimal dose of Japanese patients with malignant diseases was judged to be 100-200 micrograms/m2 by 30 minutes infusion and 75 micrograms per body by subcutaneous injection. Neutrophils were increased dose-related while other blood components did not increase. When gamma hG-CSF was used following chemotherapy, it enhanced the nadirs of leukopenia and reduced significantly durations of neutropenic periods. Bone pain was characteristic side effect and occurred dose-dependently but generally mild.