A clinical trial of cell-wall skeleton of BCG in chemoimmunotherapy of acute leukemia.

A clinical trial of chemoimmunotherapy using cell-wall skeleton of BCG (BCG-CWS) was conducted in 28 patients with acute leukemia in complete remission. Chemotherapy consisted of monthly intensification therapy for 2 months and bimonthly therafter. Immunotherapy with 200 microgram of oil-attached BCG-CWS mixed with 10(7) autochthonous leukemic cells was given intradermally at either of upper or lower extremities every week, except when the patients were on maintenance therapy. No serious systemic side effect attributable to BCG-CWS was noted. Six patients developed mild and transient temparature elevation. Most importnat side effect was local skin reaction. Indulated papules developed in all patients, resulting in draining ulcerations in 26 patients. Increase of immunological reactivity of the patients receiving BCG-CWS was noted. Skin test response to PPD, Varidase, and candida extract showed definite increase. In vitro lymphocyte blastogenic response to PPD, concanavalin-A, and pokeweed mitogen revealed significant increase.